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- 2026-04-03 19:52:00
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- Baxter’s Renal Care Unit spinoff Vantive is launched
- by Whang, byung-woo Feb 06, 2025 05:56am
- With the acquisition process complete for Baxter's Renal Care business, it has newly launched as Vantive, a new company specializing in kidney and life-sustaining organ therapies. The spin-off follows the acquisition of Baxter's Kidney Care business by funds managed by global investment firm The Carlyle Group. As an independent company, Vantive will focus on raising the standard of kidney and vital organ care to help patients around the world live richer, longer lives. Its strategy for advancing life-sustaining organ care will empower patients and healthcare providers to take more control of their care by helping to break down barriers to starting and maintaining treatment. In particular, Vantive will build on its 70-year legacy of innovation in kidney care to fulfill its mission of “Extending Lives, Expanding Possibilities.” “For patients starting dialysis and for caregivers struggling to save lives in the intensive care unit, it's critical to provide the right treatment at the right time,” said Chris Toth, CEO of Vantive. ”Our core focus is to support patients and caregivers in these moments by providing better choices, greater autonomy, and greater possibilities. “Vantive is ushering in a new era of innovation in life-sustaining long-term care, and we look forward to working with our 23,000 employees around the world to make a difference for millions of patients and families.” Vantive provides innovative products, digitally enhanced solutions and advanced services to support dialysis at home and in the hospital, and treatment options to support kidney and vital organ function in critically ill patients. Patients in more than 100 countries around the world use Vantiv's solutions and services more than one million times every day, representing an opportunity to deliver more than one million improved treatment experiences every day. Through innovative integrated devices, Vantive also aims to help healthcare providers deliver care more efficiently and patients receive treatment while maintaining their daily routines. “The launch of Vantive marks a significant milestone in the continued evolution of kidney care and life-sustaining organ support,” said Kieran Gallahue, Chairman of the Board of Directors at Vantive. ”Vantive is focused on providing better connectivity, visibility, and insight throughout the patient's care journey. Robert Schmidt, Global Co-Head of Carlyle Healthcare, added, “We are excited to partner with Vantive to expand its global impact and realize sustainable growth. In this new journey, we look forward to actively supporting Vantive's ongoing innovation to improve patient access to care, quality and outcomes, and clinician efficiency.
- Company
- Imminent launch of the 3rd new CAR-T-cell therapy 'Yescarta'
- by Eo, Yun-Ho Feb 06, 2025 05:56am
- Product photo of Gilead Sciences The third CAR-T-cell therapy 'Yescarta' is expected to be commercialized in South Korea. According to industry sources, Gilead Sciences submitted documentation for the approval of the CAR-T-cell therapy, Yescarta (axicabtagene ciloleucel), and the Ministry of Food and Drug Safety (MFDS) is currently conducting the review. Yescarta was designated an orphan drug by the MFDS in September last year. The designated indication includes ▲Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or primary mediastinal B-cell lymphoma (PMBCL) who have undergone two or more systemic treatments ▲Adult patients with DLBCL who have relapsed or refractory within 12 months after the first-line chemoimmunotherapy. Yescartav is a CAR-T cell therapy that received the first approval from the U.S. Food and Drug Administration (FDA) as the third-line treatment in October 2017. After receiving approval from the European Commission (EC), the drug has expanded to the second-line treatment. In 2021, it became available for use in treating follicular lymphoma. The efficacy of Yescarta as the third-line treatment has been confirmed through the ZUM-1 clinical study. The study reported a 5-year survival rate, showing that 42.6% of all patients treated with Yescarta survived for five years, and 92% of those no longer needed additional cancer treatment. The ZUMA-7 Phase 3 clinical trial confirmed the drug's efficacy for the second-line treatment. It was the first-in-class for a CART-T cell therapy, the largest in scale, and the longest follow-up trial. 359 patients world-wide were randomly assigned to receive one-time treatment of Yescarta or the existing standard-care second-line therapy. The analysis results presented at the American Society of Clinical Oncology conference (ASCO 2023) last year included a median follow-up at 47.2 months, at which the median value of overall survival (OS) with Yescarta was not reached. However, Yescarta's death rate was 27%, which was statistically lower than the control group's 31.1 months. The OS at 48 months was 54.6% for Yescarta and 46.0% for the control group. Yescarta treatment showed consistent survival benefits in pre-assigned subgroups, including age groups, refractory at the first-line therapy, early relapse, or high-grade B-cell lymphoma (HGBL). Additionally, excluding the impact of treatment switching using the pre-assigned method, Yescarta's risk of death was 39% lower than the control group. In South Korea, Novartis Korea's 'Kymriah (tisagenlecleucel)' was the first CAR-T-cell therapy to receive approval. In March 2024, Janssen Korea's 'Carvykti (ciltacabtagene autoleucel)' also received approved. Kymriah is now added to the insurance reimbursement list, and Carvykti is still a non-reimbursed drug.
- Policy
- Imlunestrant becomes first reviewed after new drug approval
- by Lee, Hye-Kyung Feb 06, 2025 05:56am
- The first application for a new drug license has been submitted since the fee for drug approval was raised to KRW 410 million. According to industry sources on the 6th, the multinational pharmaceutical company Eli Lilly applied for an marketing authorization for its breast cancer drug 'Inrulio (imlunestrant)' to the Ministry of Food and Drug Safety on Jan. 31. This is the first new drug application filed since the MFDS drastically improved its new drug approval review process and revised the new drug approval review fee. The MFDS implemented the New Drug Approval Innovation Plan on January 1, 2025, and introduced various improvements to increase the transparency and predictability of the approval process. The biggest change is the introduction of a preliminary consultation process. Previously, discussions could only be held after the submission of a new drug application, but now preliminary consultations can be held before submission to prepare for the approval process. This allows companies to get an early indication on the direction of data required for their new drug approval applications and minimize unnecessary supplement requests. Lilly has also already held one preliminary consultation session for Inrulio and the MFDS is currently finalizing the establishment of a dedicated team for its review within its organization. In addition, during the first and second rounds of supplement requests, a process has been added to allow pharmaceutical companies to pre-register supplement materials and request a clarification meeting. This will allow the MFDS to provide clear guidelines, and a final meeting will be held at the final review stage, which is expected to increase the consistency and efficiency of the approval process. Based on such innovative measures, the MFDS aims to shorten the review period for new drugs to 295 days or less, and in particular, the GMP survey period has been significantly shortened from 12 months to 90 days. This is expected to speed up the time for new drug releases. Lilly's Inrulio is the domestically licensed name for imlunestrant, an oral selective estrogen receptor degrader (SERD). The drug is being developed for the treatment of patients with estrogen receptor-positive (ER+), and hormone receptor 2-negative (HER2-) advanced breast cancer. Results from the recently announced Phase III EMBER-3 trial showed that imlunestrant provided a statistically significant improvement in progression-free survival (PFS) compared to standard-of-care endocrine therapy (SOC ET). In particular, patients with estrogen receptor 1 (ESR1) mutations experienced a 38% reduction in tumor worsening compared to conventional therapy. In addition, the combination of imlunestrant and the CDK4/6 inhibitor Verzenio (abemaciclib) reduced the rate of tumor worsening by 43% compared to monotherapy, with a median progression-free survival of 9.4 months compared to 5.5 months for imlunestrant alone. The findings were published in the New England Journal of Medicine (NEJM) and presented at the San Antonio Breast Cancer Symposium (SABCS). This application is the first to be submitted since the implementation of the new drug approval innovation plan and will be an important test of how quickly and efficiently the MFDS’s new approval process will work. The MFDS had said, “ We will establish a review system that stands at the global level through the new drug approval innovation plan. The review process with increased transparency and predictability will contribute to strengthening the competitiveness of Korea’s pharmaceutical industry.” “This is a positive sign that the domestic new drug review process is evolving to a global level,” said a pharma and bio-industry official. ”If the new drug launch period is shortened through this innovation plan, domestic patients will be able to access innovative treatment options more quickly.” Another industry expert said, “If the MFDS's expedited approval process works smoothly, not only global pharmaceutical companies but also domestic biotech companies will be able to more actively engage in new drug development,” and “Increasing the efficiency of the new drug approval process will have a positive impact on the entire industry.”
- Policy
- Reimb imminent for switching between atopic dermatitis drugs
- by Lee, Tak-Sun Feb 05, 2025 05:53am
- Switching between atopic dermatitis drugs may be reimbursed soon. This is because the National Health Insurance Service has completed its review through the preliminary drug price reduction system, and all that remains is the National Health Insurance Service's negotiations. As the expected claim amount is not large, the negotiations are expected to be completed without difficulty. According to industry sources on the 3rd, the Health Insurance Review & Assessment Service (HIRA) has completed its review on expanding reimbursement to cross-administration between biological drugs and JAK inhibitors through the preliminary drug price reduction system and reported it to the Ministry of Health and Welfare. The review was completed after the Drug Reimbursement Evaluation Committee, which was held on January 9, recognized the appropriateness of the reimbursement benefits and collected opinions from pharmaceutical companies. Relevant pharmaceutical companies have not submitted separate objections on the agenda. In the case of expanding the scope of use, if the expected additional claim is less than KRW 1.5 billion, the drug price reduction will not be applied, and if it is between KRW 1.5 billion and 10 billion, a preliminary price reduction will be applied, and if it is over KRW 10 billion, drug price negotiations will be conducted. This cross-administration between biological drugs and JAK inhibitors was subject to a preliminary drug price reduction, and the drug price reduction rate for individual products was determined according to the formula. The target items include biologics such as Dupixent (dupilumab) and Adtralza (tralokinumab), and JAK inhibitors such as Rinvoq (upadacitinib), Olumiant (baricitinib), and Cibinqo (abrocitinib). If approved, most patients will be switching from biological drugs to JAK inhibitors, which will likely lead to an increase in the amount of claims for JAK inhibitors. However, the amount of additional claims is not expected to be high. Accordingly, industry insiders believe that the drug price reduction rate may well be determined based on the formula without drug price negotiations, Even if the NHIS enters drug price negotiations, the industry believes that it will be easy to reach an agreement as the level of the expected additional claims amount will be low. It is analyzed that cross-administration may be reimbursable from March at the earliest after being reported to the Health Insurance Review and Assessment Service. Meanwhile, the current reimbursement standard requires that patients with severe atopic dermatitis who have used biological agents or JAK inhibitors to have first administered the first-line treatment for 3 months and meet the criteria of Eczema Area and Severity Index (EASI) 23 or higher to switch to other drugs. The regulations made it difficult to immediately replace the drug even if side effects occur or the treatment is ineffective, so healthcare professionals have urged the government to reimburse cross-administration without conditions. Health authorities have been considering expanding reimbursement of cross-administration between biological agents and JAK inhibitors since last year.
- InterView
- "High hopes for reimbursed Ilaris…a new treatment option"
- by Whang, byung-woo Feb 05, 2025 05:52am
- The Hereditary Periodic Fever (HPF) syndromes cause not just fever and pain but affect various aspects, such as patient's growth and development, psychological elements. The reimbursement coverage of a new treatment in nine years has increased patient satisfaction." Clinical practices have high hopes for changes to the treatment setting as Ilaris (canakinumab), a treatment for Hereditary Periodic Fever (HPF) syndromes, passed the reimbursement hurdle nine years after approval. Although doctors still face difficulties finding the appropriate dosage, analysis suggests that reimbursement will solve unmet needs for ultra-rare disease treatment where treatment options have been limited. Experts believe that systematic improvements are needed to overcome the limitations, such as genetic testing, in the long term. Dr. Soyoung Lee, Professor of Pediatric & Adolescent Medicine at Hallym University Sacred Heart HospitalDaily Pharm met with Dr. Soyoung Lee, a Professor of Pediatric & Adolescent Medicine at Hallym University Sacred Heart Hospital, with years of prescribing experience, and heard about changes to HPF syndrome treatment settings following reimbursement coverage of Ilaris. The HPF syndromes are rare autoinflammatory diseases that occur shortly after birth or in childhood. Unexplained and periodic episodes of full body fever and rashes characterize these diseases. The HPF syndromes are categorized into various disorders based on abnormal genes. Symptoms such as fever and rashes most commonly occur, but other symptoms vary by disorder. "In my opinion, it is more suitable to call this disorder periodic fever syndromes (PFS) rather than the HPF syndromes," Dr. Lee said. "In contrast to other autoimmune diseases, these disorders are categorized as autoinflammatory disorders. A single gene causes some of these disorders, whereas several genes are indicated to contribute to the disorder," Dr. Lee explained. In South Korea, common cases include Cryopyrin-Associated Periodic Syndrome (CAPS), Familial Mediterranean Fever (FMF), Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS), and Hyper IgD Syndrome (HIDS). These disorders are all single-gene disorders. According to Dr. Lee, the most common treatments for these disorders include nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids to alleviate pain and fever. "In 2010, the introduction of the IL-1 inhibitor Anakinra allowed for the replacement of steroids, enabling most patients to discontinue unnecessary medications. However, since the injection had to be administered daily at a fixed time, patients faced significant challenges," Dr. Lee remarked. "Typically, the dosage of the medication must be increased depending on the severity of the disease/ Because of the limitation of dosage that can be administered at a single injection, patients often suffer serious pain, and the other problem is that the required dosage required two separate injections," Dr. Lee stated. In other words, Dr. Lee says that existing treatments had limitations in terms of long-term effects and patient quality of life despite the nature of HPF syndromes in affecting various aspects, such as patient's growth and development, psychological elements, and causing fever and pain. "Reimbursed Ilaris provides benefits in terms of treatment effects‧administration interval" Changes to the treatment setting have been apparent since August of last year, following reimbursement coverage of Ilaris for CAPS, TRAPS, and FMF." What changes have been made to the treatment setting with reimbursed Ilaris? Dr. Lee says only few cases can be compared because it is a rare disease, but reimbursed Ilaris provided significant benefits in symptom improvements and improved patient quality of life. "As patients switch to Ilaris based on insurance criteria, there have been no cases where patients gave up treatment despite the process being tough finding the appropriate dosage after starting with a low dosage," Dr. Lee said. "Since the administration interval is longer than the other treatments, patients can now be treated with more freedom." "Additionally, patients can get injections at the hospital, so they are now freed from the burden of being injected at home by non-experts," Dr. Lee added. "The half-life of Ilaris is about 26 days, which minimizes the burden of drug administration time. Consequently, Ilaris provides a crucial turning point for patients." While reimbursed Ilaris provides various benefits, the remaining issues are the dosage and managing side effects due to the longer administration interval. Depending on the type of HPF syndromes, Ilrais is given every 8 weeks or 4 weeks. Doctors are concerned about dosage adjustment or symptom management if symptoms occur during treatment. "The process of determining the appropriate dosage was not easy, but all five patients currently undergoing treatment have found their optimal dose and are continuing treatment stably," Dr. Lee said. "Although it has been just over four months since starting Ilaris, we now have more flexibility in adjusting the dosage for the next cycle while closely monitoring weight gain and symptoms." Adjusting treatment dosage remains a challenge…"We must consider a patient-customized treatment" Yet, another challenge is to help patients with HPF syndromes to receive reimbursement coverage. "Currently, Ilaris can only be used if a patient's genetic mutation is confirmed. However, genetic testing fails to provide a diagnosis in up to 40% of cases." Dr. Lee added, "According to foreign studies, despite advancements in genetic analysis technology, 20–30% of cases still rely solely on clinical diagnosis to initiate treatment, highlighting the need for further discussion on this issue." "Because the starting dosage is set too low, patients face challenges finding appropriate dosage. If the system is improved so that dosages can be flexibly determined under the doctor's supervision, patient-customized treatment will offer better treatment settings," Dr. Lee mentioned. Ultimately, Dr. Lee highlights the need for efforts to improve the diagnostic rate of the HPF syndromes, which is a rare disease, in the long term. "The number of patients with CAPS is recorded to be 2 plus 3 in 2022, but more undiagnosed patients likely exist," Dr. Lee said. "To provide more accurate and professional information, we hope academic organizations provide educational sessions for doctors interested in this field." Dr. Lee added, "Genetic testing is an important tool for diagnosing (very) rare diseases, but its usefulness assessment varies by how it is used. "In my opinion, it is more effective to conduct genetic testing only when doctors determine it is necessary, after thoroughly evaluating the patient's symptoms and diagnostic course."
- Policy
- Low-dose nicergoline continues to be popular
- by Lee, Hye-Kyung Feb 05, 2025 05:52am
- Although it does not indicate the primary treatment of dementia, companies continue to receive approval for their low-dose nicergoline products. .The Ministry of Food and Drug Safety (MFDS) approved Reyon Pharm’s ‘Nicechol Tab .10mg’ on the 3rd .This is the second approval this year, following the approval of the ‘Neurogoline Tab .10mg’ in January .Nicergoline is an α1-adrenergic receptor antagonist that dilates blood vessels to increase arterial blood flow, inhibits platelet aggregation by enhancing neurotransmitter function, and promotes metabolic activity .니세르골린 10mg 용량 허가 품목. Among low-dose nicergoline, Hanmi Pharm’s ‘Nicegoline Tab .10mg’ was the only drug to be approved after 27 years, following Ildong Pharmaceutical's original nicergoline product, ‘Sermion Tab.’ However, new products are being approved lately as the 30mg high-dose product is emerging as a substitute for 'choline alfoscerate,' which is currently subject to clinical and reimbursement reevaluation .Pharmaceutical companies are additionally applying for marketing authorization after demonstrating bioequivalence between its 10 mg and its already-approved 30mg product through comparative dissolution tests .The 10 mg dose is used to ▲ improve the loss of motivation caused by chronic cerebral circulatory disorders that accompany the aftereffects of cerebral infarction, ▲arteriosclerotic headaches in the elderly, and ▲as an adjunctive therapy for hypertension .The 5 to 10 mg dose is administered orally three times a day before meals .So far, a total of 15 nicergoline 10 mg products and 38 high-dose products have been approved in Korea .In the case of primary prevention and treatment of dementia, it is possible to increase the dose up to 60 mg after the initial 30 mg prescription, so it is interpreted that pharmaceutical companies have set out to secure approval for a variety of doses by obtaining approval for not only for high doses but also low doses .Nicergoline 30 mg is indicated for ▲the primary treatment of the following dementia syndromes associated with primary degenerative vascular dementia and mixed dementia: memory impairment, concentration disorder, judgment disorder, and lack of initiative .Meanwhile, according to global market research firm QYreserach, the global nicergoline market is expected to grow at an annual average rate of 16.6% to reach USD 2.3547 billion (about KRW 3.14 trillion) by 2029.
- Company
- 1st to exceed KRW 1T sales…Pfizer's ESG initiatives
- by Whang, byung-woo Feb 05, 2025 05:52am
- Health Insight by Reporter Whang, byung-woo Pfizer Korea, the first to exceed KRW 1 trillion in sales from COVID-19 vaccine·treatments, continues strengthening its sustainable business management based on the ESG initiative. After recording KRW 3 trillion in 2022 during the COVID-19 pandemic, Pifzer Korea's sales robustly decreased. However, despite unusual circumstances, the industry assesses that the company ensured internal stability afterward. Also, Pfizer Korea launched the 'An Accord for a Healthier World (Health Equity)' study and appears to be expanding its influence in all ESG aspects, including pursuing long-term projects. Major achievements during the COVID-19 pandemic…anticipates securing a stable source of sales Pfizer Korea's past few years can be summarized with the keyword 'COVID-19.' The company's sales robustly increased since 2021 after supplying the COVID-19 vaccine Comirnaty and the COVID-19 treatment Paxlovid. Pfizer Korea's sales reached ▲KRW 391.9 billion in 2020 ▲KRW 1.694 trillion in 2021 ▲KRW 3.2254 in 2022. However, the 2023 sales amounted to KRW 1.6018 trillion, down 50.3% from the previous year. Analysis suggests that the sales were reduced in half due to decreased COVID-19 patients transitioning to the endemic. Because distribution and marketing of the COVID-19 vaccine·treatment required minimal SG&A costs since the government primarily handled these, Pfizer Korea could generate high revenue. Pfizer Korea The sales trend for 2024 is yet unavailable. However, based on global sales, a significant drop, such as those observed in 2023 compared to 2022, seems unlikely. Pfizer's Q3 sales last year recorded US$ 17.7 billion (approximately KRW 24.4 trillion), up 31.2% Year-over-Year (YoY). Pfizer's net sales from Q1 to Q3 last year amounted to US$45.864 billion (approximately KRW 63.47 trillion), up 2.0% from the same period of the previous year. Such sales growth was driven by the COVID-19 pharmaceuitcals. The COVID-19 treatment Paxlovid generated US$ 2.7 billion in Q3, which robustly increased by 1238.1% YoY. Based on these statistics, Pfizer believes that the sales index for the COVID-19 vaccine·treatment has entered a stable period. Despite experiencing robust increases and decreases in sales during the COVID-19 pandemic, Pfizer believes its potential sales are now predictable as the COVID-19 vaccination became mandated for the high-risk group. The South Korean government also actively secured treatments by adding Paxlovid to the reimbursement list. Pfizer recently estimated 2025 sales to reach around US$ 61 billion (KRW 88 trillion) to US$ 64 billion (KRW 93 trillion). It may not be close to the sales of US$ 100 billion (KRW 145 trillion) in 2022, but the company is likely to continue growth compared to the sales of US$ 58.5 billion (KRW 85 trillion) in 2023. Sales trend of Paxlovid and Comirnaty (unit: US$ 1 million). BLUE: Paxlovid, Gray: Comirnaty Cash cow sources following the pandemic…hopes for pneumococcal‧RSV vaccines대 Because COVID-19-related sales are expected to be limited, Pfizer needs a new cash cow to drive sales growth. As part of its mid-to-long-term growth strategy, Pfizer aims to strengthen its position in the oncology sector by launching eight new drugs expected to generate over US$1 billion (approximately KRW 1.3 trillion) in sales by 2030. For this goal, Seagen, an antibody-drug conjugate (ADC) specialist company that Pfizer acquired for US$ 43 billion (approximately KRW 55 trillion), is involved. Seagen has developed various ADC-based cancer therapies, including Adcetris, Padcev, and Tukysa. Pfizer plans to establish a blockbuster drug portfolio centered on Seagen’s ADC therapies alongside its existing targeted cancer treatments, such as Ibrance for breast cancer and Lorbrena for lung cancer. Given the momentum from the Seagen acquisition, Pfizer projects revenue from non-COVID-19 products to reach US$ 70 billion to US$ 84 billion (approximately KRW 95 trillion to KRW 114 trillion) by 2030. Additionally, Pfizer has launched a global cost reduction initiative. Through its 'Cost Realignment Program,' the company aimed to cut US$ 4 billion (approximately KRW 5.2 trillion) in spending by 2024. Pfizer has also announced plans to further reduce costs by an additional US$ 1.5 billion (approximately KRW 2.1 trillion) by 2027. CEO of Pfizer Albert Bourla stated, "Through the Cost Realignment Program, we successfully achieved our goal of reducing US$ 4 billion (KRW 5.8332 trillion) in net operating costs by 2024. We also expect to secure an additional US$ 500 million (KRW 729.1 billion) in 2025." Bourla added, "To further improve profitability, we will continue advancing our manufacturing optimization program this year." Pfizer In the Korean market, many new products are expected to challenge the market. One notable product is Prevenar 20, which received approval from the MFDS in November last year. It is a new pneumococcal vaccine that Pfizer is introducing in 14 years. The vaccine added seven new serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F, 33F) to the existing Prevenar 13. The vaccine is projected to launch in the early half of the year. Since it has established solid ground in the global market, Prevenar 20 is anticipated to land quickly. Mylotarg (gemtuzumab ozogamicin) for acute myeloid leukemia (AML), which has not been reimbursed, and 'VYNDAMAX (tafamidis)' for cardiomyopathy, which is near drug price negotiations with the HIRA, is expected to affect the sales for 2025. Also, Pfizer's RSV vaccine is expected to be submitted for approval process this year. RSV is regarded as a new market opportunity. Products have been approved or launched, GSK for adults and Sanofi for children, experts analyze that Pfizer, with adults and children indications, still has a chance in the competition. Driven ESG initiatives, strengthened sustainable business management Additionally, Pfizer conducts long-term projects by expanding all aspects of ESG initiatives to meet the goal to pursue social value and continue efforts. Pfizer Korea launched the ESG initiative, 'Moves for a Healthier World,' in 2022, and has included it as one of the company goals. For instance, the company has chosen six priority areas, including ▲Climate change action ▲Pharmaceutical innovation ▲Equitable Access to medicines ▲Diversity, Equity, and Inclusion ▲Pharmaceutical quality and safety ▲Company ethics, and has taken action on sub-projects. As part of the Green Moves Campaign, Pfizer Korea recently donated KRW 10 million to the 'School Forest Project' hosted by the Forest for Life. In collaboration with Pusan National University's Research and Business Development Foundation, Pfizer also commenced the 'Study to Develop Index and Analyze Social Determinants for Health Equity Across the Life Course' involving Korean citizens. This project aims to assess healthcare inequality and enhance societal interest in alleviating the healthcare gap by focusing on increased healthcare inequality and losses in socially disadvantaged classes after the COVID-19 pandemic. Additionally, Pfizer also holds various activities to enhance social value, including the 'Pfizer Medical Research Award,' which is in its 22nd year, and the Work Program for Young Disabled People. Pfizer Korea CEO Dong-Wook Oh stated, "Pfizer Korea aims to realize 'Moves for a Healthier World' and continues efforts to bring positive changes to Korean society." Oh added, "The program covering all ESG aspects reflects Pfizer's goal and efforts to bring changes so that all people can experience a healthier world." "The 'Health Equity' project launched last year will be our first crucial step in assessing Korea's healthcare equity state and establishing measures to improve the system," Oh added. "By closely collaborating with Korean researchers, Pfizer will strive to help people to stay healthy."
- Company
- Multiple sclerosis drug Ocrevus may soon be reimbursed
- by Eo, Yun-Ho Feb 05, 2025 05:52am
- The new multiple sclerosis drug Ocrevus is expected to be listed for reimbursement in Kore. According to industry sources, Roche Korea has completed negotiations with the National Health Insurance Service on the drug price of Ocrevus (ocrelizumab) for relapsing multiple sclerosis (MS). As a result, the drug is expected to be reimbursed once it passes the Health Insurance Policy Review Committee review. The company is moving quickly to finalize the reimbursement process, given that it submitted the application for reimbursement after its domestic approval in May last year. Ocrevus targets CD20-expressing B cells that affect the demyelinating process that causes neurological disorders in MS patients. MS is a chronic disease in which myelin is damaged by an autoimmune inflammatory response. Damage to the myelin sheath causes symptoms such as muscle weakness, fatigue, and vision impairment, and can lead to non-traumatic disability. As of 2022, an estimated 2,674 patients in Korea are known to be suffering from MS, with those in the 20-40 age group accounting for more than 62% of the total. Antibody therapies such as Tysabri (natalizumab), Gilenya (fingolimod), and Mabthera (rituximab) have been utilized in the disease area, but there has been a steady demand for additional high-efficacy drugs. Various new drugs have been developed overseas, including Novartis' Kesimpta (ofatumumab) and TG Therapeutics' Briumvi (ublituximab), but Roche's Ocrevus is the only one introduced in Korea. Ocrevus also has the advantage of offering a shorter dosing period. Ocrevus can be administered once every 6 months, which is more convenient than Kesimpta (administered once every month). The approval was based on the Phase III OPERA-I and II studies. The studies evaluated the efficacy and safety of Ocrevus versus Biogen's interferon therapy Plegridy (interferon beta-1a) in patients with relapsing MS. In the trial, Ocrevus reduced the annualized relapse rate (ARR) by nearly half compared to Plegridy. Specifically, in the OPERA I study, the ARR was 0.156 for 96 weeks of Ocrevus versus 0.292 for the control arm, and in OPERA II, the ARR was 0.155 for 96 weeks of Ocrevus versus 0.290 for the control arm. Ocrevus also showed efficacy in the Phase III ORATIORIO study in patients with primary progressive MS. In this study, Ocrevus reduced the risk of confirmed disability progression (CDP) by 24% over 12 weeks compared to the control group. Ho Jin Kim, professor of Neurology at the National Cancer Center, said, “In MS, even small differences in the early stages can have huge cumulative consequences. This is why the benefits of early access to highly effective therapies are significant. These treatments will not only improve patients’ quality of life but also help reduce the cost of the disease to society and the economy. Ocrevus is well positioned to be utilized because it has sufficient data established not only in terms of efficacy but also on long-term treatment administration.”
- Company
- Hepatitis B drug market remakes ₩300B after 6 years
- by Kim, Jin-Gu Feb 04, 2025 05:55am
- The outpatient prescription market for hepatitis B drugs expanded again last year to exceed KRW 300 billion. This is the first time the market has exceeded the mark in 6 years since 2018. Gilead Sciences’ Vemlidy drove the market growth with a 15% increase in sales from KRW 61.9 billion to KRW 71.3 billion in 1 year, while the combined prescription volume of tenofovir-based generic products increased by 21%. Hepatitis B drug market re-enters KRW 300 billion range for the first time in 6 years According to the market research institution UBIST on Wednesday, the outpatient prescription market for hepatitis B drugs was KRW 303 billion last year. This is a 4% increase from the KRW 292.3 billion in 2023. The market has re-entered the KRW 300 billion range for the first time in six years since 2018. The market was valued at over KRW 300 billion in 2018 but declined to KRW 273.1 billion in 2019. This was due to the patent expiry of Gilead Science’ Viread, the market leader at the time, and the corresponding reduction in Viread’s drug price. The market further shrank to KRW 266 billion in 2020. In 2021, the market rebound. In 2021, it grew by 4% to KRW 275.6 billion. In 2022, it grew to KRW 283.8 billion and in 2023 to KRW 292.3 billion, a 3% increase for 2 consecutive years. It expanded further to exceed KRW 300 billion last year. Vemlidy grows 15% in one year...No. 2 in the market Gilead's Vemlidy led the market growth. Last year, Vemlidy’s prescriptions totaled KRW 71.3 billion, up 15% from the previous year. Vemlidy is Gilead’s new hepatitis B drug that was developed as a successor to Viread. While the original Viread was highly effective in suppressing the hepatitis B virus, it was criticized for its side effects, including kidney dysfunction and decreased bone density. Vemlidy overcame these shortcomings. In clinical trials, no adverse events, including renal dysfunction and decreased bone density, were found in patients using Vemlidy. Long-term safety was also highlighted as an advantage given the difficult-to-cure nature of hepatitis B. In fact, sales of Vemlidy have steadily increased since its launch in Korea in 2017, making up for the decline in Viread’s prescription performance. In 2019, it surpassed KRW 10 billion in prescriptions, and in 2021, it expanded to exceed KRW 30 billion. This was followed by a further increase to KRW 49.2 billion in 2022 and KRW 61.9 billion in 2023. In particular, last year, it reached KRW 71.3 billion, overtaking BMS Baraclude (KRW 71.9 billion), the No. 2 product in the market. Given Baraclude’s recent sales decline, the industry expects Viread will overtake Baraclude and become the No. 2 product within this year. While Gilead's prescription sales were down 1% YoY, the company’s still stays strong at more than KRW 90 billion. By 2019, the company was generating more than KRW 100 billion in annual prescription sales. Since then, it has switched to Vemlidy, and its prescription performance has been declining moderately. In addition, original items from domestic and foreign pharmaceutical companies have recently seen a slowdown in prescription sales. Ildong Pharmaceutical's Besivo (besifovir) generated KRW 2.3 billion in sales last year, the same as in 2023. The sales of Bukwang Pharm’s Sebivo (telbivudine) decreased from KRW 1.2 billion to KRW 1 billion, and the sales of Levovir (clevudine) remained at KRW 800 million each in 2023 and 2024. Levovir’s patent term expires in April 2022. Sales of GSK’s Zeffix (lamivudine) fell slightly from KRW 3.3 billion to KRW 3.2 billion in 1 year. Sales of GSK’s other product, ‘Hepsera (adefovir)’ have not been counted since the company withdrew the drug’s domestic license in 2022. Vemlidy generics enter market in full scale…sales of tenofovir-based generics jump 21% in the US Generic tenofovir drugs have also seen a significant increase in sales. Last year, the combined prescription value of tenofovir generics was KRW 20.7 billion, up 21% from KRW 17.1 billion in 2023. In Korea, generic versions of tenofovir-based hepatitis B treatments have been launched in succession since 2018 for Viread and 2023 for Vemlidy. In the case of tenofovir-based generics, the growth was somewhat slower, with the existing Viread generics generating KRW 15.9 billion in 2020, KRW 16.5 billion in 2021, KRW 17.7 billion in 2022, and KRW 17.1 billion in 2023. However, the entry of Vemlidy generics has grown the market significantly to reach KRW 20.7 billion. The prescription performance of existing Viread generics has mostly declined. Chong Kun Dang’s Tenofobell fell from KRW 3.7 billion in 2023 to KRW 3.3 billion last year. Dong-A ST’s Virreal fell from KRW 2.8 billion to KRW 2.6 billion. On the other hand, Vemlidy generics saw a significant increase in prescriptions. Samil Pharmaceutical's Vemlino generated only KRW 300 million in 2023 but increased eightfold to KRW 2.4 billion last year. Sales of Dong-A ST’s Vemlia also surged from KRW 300 million to KRW 1.7 billion in one year. Generic versions of another hepatitis B drug, Baraclude, generated KRW 33.6 billion last year. The combined prescription value of Baraclude generics has been growing moderately since exceeding KRW 30 billion in 2020. Among Baraclude generics, Dong-A ST’s Baracle was the highest prescribed at KRW 10.4 billion. It was followed by Samil Pharmaceutical's Enped at KRW 3.8 billion, Daewoong Pharmaceutical's Baracross at KRW 3.4 billion, Bukwang Pham’s Bukwang Entecavir at KRW 3.2 billion, and Hanmi Pharmaceutical's Cavir at KRW 3 billion.
- Company
- 'Tibsovo' reapplies for bile duct cancer indication reimb
- by Eo, Yun-Ho Feb 04, 2025 05:55am
- Product photo of Tipsovo 'Tibsovo,' which is indicated for the treatment of bile duct cancer (cholangiocarcinoma) and acute myeloid leukemia (AML), reapplies for obtaining insurance reimbursement. According to industry sources, Servier Korea has submitted a reimbursement application for cholangiocarcinoma indication of Tibsovo (ivosidenib), a drug targeting the isocitrate dehydrogenase 1 (IDH-1) gene mutation. If a patient is tested positive for IDH1 mutation, Tibsovo can be used as a ▲Monotherapy in patients with locally advanced or metastatic AML and had prior therapy ▲Combination therapy with 'azacytidine' in adult patients over 75 years with accompanying disease that cannot be treated with chemotherapy. Tibsovo's AML indication passed the Health Insurance Review and Assessment Service (HIRA)'s Cancer Disease Review Committee (CDRC) in October of last year. Yet, the cholangiocarcinoma indication has not passed the CDRC review. It remains to be seen if Tibsovo, effective in treating cholangiocarcinoma, where treatment options are limited, will be considered for reimbursement. Cholangiocarcinoma is a cancer with a poor prognosis. The five-year relative survival rate is only 28.9%. 65% of the patients with cholangiocarcinoma of the liver are found be non-operable when diagnosed. Tibsovo is the only targeted drug recommended as a Category 1, the highest grade, by the National Comprehensive Cancer Network (NCCN) for a second-line treatment for cholangiocarcinoma. According to ClarlDHy Phase 3 clinical trial, Tibsovo reduced the disease progression by 63% compared to a placebo and had a median progression-free survival (PFS) of 2.7 months (placebo 1.4 months). Also, patients treated with Tibsovo had a median overall survival (OS) of 10.3 months, which was longer over twice than 5.1 months of those treated with a placebo. Do-Youn Oh, Professor of Department of Hematology-Oncology at Seoul National University Hospital, said, "Over the last five years, the development of treatments for cholangiocarcinoma got fast. Along with new drug development, many companies are focusing on developing drugs for cholangiocarcinoma. Patients with cholangiocarcinoma need to follow physician's advice, receive treatments, and seize new opportunities such as participating in clinical trials." Meanwhile, in the AGILE Phase 3 trial involving patients with AML, Tibsovo was demonstrated to improve event-free survival (EFS) when combined with azacytidine, and the overall survival (OS) was significantly improved. The patients treated with Tibsovo had a median OS of 24.0 months (placebo 7.9 months). In a long-term follow-up study, the median OS of Tibsovo combination therapy was 29.3 months, over 3.7-fold longer than that of placebo combination therapy.
