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- 2026-05-01 11:20:51
- 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.
- Opinion
- [Reporter's View] Slow but steady wins the race
- by Whang, byung-woo Feb 04, 2025 05:55am
- The Korean government has finally launched the National Bio Commission. The launch of this proper control tower has come several years after the government declared the bio-health industry as a national strategic industry. The news of its launch is encouraging, considering how the launch of the committee itself was almost stranded due to various issues. However, regardless of the delay in its launch, the committee's top priority now should be focused on setting the right direction for its future. The National Bio Committee was established to organically connect the policies being pursued individually by related organizations through cross-ministerial top-level governance. This means that it should not be a mere show-off policy, but should be backed by substantial support and regulatory innovation. Although Korea’s biohealth industry is growing rapidly in the global market, there are still many obstacles. The overall industrial ecosystem, from new drug development to medical devices and digital healthcare, is not moving forward due to regulatory barriers. In particular, Korea’s clinical approval process for the development of innovative new drugs or medical devices is still regarded as complicated and time-consuming despite the efforts of the government. This is why domestic bio companies have been turning their eyes overseas. The role of the National Bio Committee is clear in this context. It needs to reflect the voice of industry and lead regulatory reforms to meet global standards. Of course, the government has not completely neglected the bio-industry over the past few years. However, there were many cases where policies lost consistency or were redundant due to each ministry’s separate affairs. This was why the launch of the National Bio Committee was important. It is positive that the president has personally taken the chair and organized the commission so that key ministries such as the Ministry of Science and ICT, the Ministry of Health and Welfare, and the Ministry of Food and Drug Safety could work closely together. However, just creating an organization is not enough to solve the problem. Setting clear goals and executing them quickly is of the utmost importance. At the first meeting of the National Bio Committee, the government announced that it would first build a 'Korean-style bio cluster.’ Although the need for its resolution has been consistently mentioned, it is also true that doubts have been cast on its effectiveness, as it is an age-old issue that has not been resolved for various reasons over the years. It is necessary to consider whether it is appropriate to launch a new committee if the committee’s goal stands at just wrapping up what has been done so far as if it were new. The industry had expressed concern that the commission might have little role to play before its launch. This is because the pharmaceutical and bio sector, which is a new growth engine, needs stronger leadership support. The role of the National Bio Committee is simple. The aim is to support companies’ focus on the development of new drugs and medical devices and to reorganize regulations in a way that promotes innovation. It is essential to strategically foster next-generation technologies, such as cell and gene therapies, mRNA vaccines, and AI-based drug development, which global pharmaceutical and biotechnology companies are competing to invest in. Rather than focusing on short-term results, policies that change the nature of the biohealth industry are necessary from a mid to long-term perspective. The domestic bio-industry has much growth potential. However, if the government fails to play its role, companies that run into obstacles will only experience limitations. Proper support must be provided for this now. Although it is late, in the right direction, there is still time for Korea’s industry to catch up. It is this reporter’s hope that the launch of the National Bio Committee will mark the starting point for the establishment of such 'proper' bio policies.
- Company
- Lixiana leads the DOAC market..generics make advances
- by Kim, Jin-Gu Feb 04, 2025 05:55am
- (Clockwise from top left) Lixiana, Eliquis, Pradaxa, and Xarelto Daiichi Sankyo's Lixiana (edoxaban) is further solidifying its dominance in the direct-acting oral anticoagulant (DOAC) market. Prescriptions grew 12% year-on-year, and its share of the total market expanded to 45%. Sales of Eliquis (apixaban) and Xarelto (rivaroxaban), on the other hand, have faltered. Eliquis saw its first year-over-year prescription decline due to generic re-entry. Xarelto generics have expanded prescriptions by 47% in a year, fiercely chasing the original. Lixiana’s sales near KRW 120 billion a year...doubled in 5 years, accelerating its dominance in the market According to the market research institution UBIST, the outpatient prescription market for DOAC was KRW 260.1 billion last year. This is a 7% increase from the KRW 242.8 billion in 2023. DOACs are anticoagulants that prevent blood clots by directly acting on blood clotting factors. It has replaced warfarin, which inhibits the metabolism of vitamin K, and expanded its use in the prescription field. Xarelto was approved in Korea in 2009, followed by Pradaxa-Eliquis in 2011 and Lixiana in 2015. When the products were first introduced, they were commonly referred to as NOACs (New Oral Anti-Coagulants), but as more than a decade has passed after their first approval, they are now referred to as DOACs (Direct Oral Anti-Coagulants), which means they act directly on clotting factors. Major DOAC prescriptions by year (Unit: KRW 100 million, Source: UBIST) Lixiana's dominance has been growing in the market. Last year, prescriptions for Rixiana totaled KRW 117.5 billion, up 12% from KRW 105.3 billion in 2023. Although Lixiana was one of the last DOACs to be launched in the market, it quickly ramped up prescriptions and has risen to become the market leader since 2019. With annual growth of around 10%, prescription sales have nearly doubled in 5 years from KRW 60.4 billion in 2019. Its share of the total DOAC market has also expanded from 33% in 2019 to 45% last year Eliquis’s sales decline for the first time...generics re-entry impact The remaining original drugs, on the other hand, have seen a recent decline. Eliquis, the No. 2 product in the market, posted prescription sales of KRW 74.3 billion last year. This is down 4% from KRW 77.3 billion in 2023. Last year was the first time Eliquis' prescription sales declined year-on-year. This decline in prescription sales is attributed to the reentry of generics and drug price cuts that followed. Last September, Eliquis' substance patent expired. This was followed by the re-entry of Eliquis generics into the market after a three-and-a-half-year break. Eliquis generics have been launched into the market one after another since June 2019. At that time, generic companies launched the product based on the verdict of the first and second material patent trials. Since then, Eliquis generics have steadily increased prescriptions in the market. However, in April 2021, the tide turned when the Supreme Court overturned the first and second trial rulings and ruled in favor of BMS. The generic companies immediately withdrew their products from the market, and Eliquis regained its monopoly position in the apixaban-based DOAC market. Quarterly prescription performance of Eliquis originals and generics (Unit: KRW 100 million, Source: UBIST) The generic drugs returned last year upon the expiry of Lixiana’s substance patent. At the same time, the price of the original product was reduced. When the generic was launched in 2019, the price cut was suspended due to BMS's administrative litigation, but last year, the 30% price cut was applied. Inluence of Xarelto generics expand...market share of rivaroxaban reach 46% Xarelto generated KRW 31.5 billion in sales last year. That's up 2% year-over-year, but the long-term decline is steady. Xarelto's prescription sales steadily declined from KRW 60.9 billion in 2021 to KRW 49.4 billion in 2022, then to KRW 31 billion won in 2023. The decline in Xarelto prescriptions was driven by patent expiry and subsequent generic launches. Xarelto generics have been available since the second quarter of 2021. Then Xarelto's price cut, which had been blocked by administrative litigations, was enforced in the third quarter of 2022. Xarelto prescriptions plummeted at the time of the price cut. Meanwhile, Xarelto generics are rapidly gaining influence in the market. Sales of Xarelto generics surpassed KRW 10 billion in prescriptions in 2022, their second year on the market. By 2023, the market had grown to KRW 18.3 billion, and last year, it rose 47% to KRW 26.9 billion. Generics' share of the rivaroxaban-based DOAC market expanded from 37% in 2023 to 46% last year. The pharmaceutical industry expects sales of Xarelto generics to surpass the original in combined prescriptions this year. Quarterly prescription performance of Xarelto original and generics (Unit: KRW 100 million, Source: UBIST) Prescription sales of major generic products increased simultaneously. Hanmi Pharmaceutical's Riroxban more than doubled from KRW 3.9 billion in 2023 to KRW 8.1 billion last year. Sales of Samjin Pharm’s Rivoxaban increased 64% from KRW 3.2 billion to KRW 5.2 billion. Sales of Chong Kun Dang’s Riroxia grew 10% year-on-year to KRW 5 billion. Sales of Pradaxa (dabigatran) have been in a prolonged slump. Last year, prescription sales fell to less than KRW 10 billion. Will Eliquis generics return to the market and replicate past gains The future of this market will be determined by how quickly generic Eliquis products, which returned to the market in September last year, will expand their influence. Some industry observers believe that the major generics companies will quickly expand their presence in the market, as they already have experience launching the products. Eliquis generics generated prescription sales of KRW 1.2 billion in 2019 and KRW 9.3 billion in 2020. In the first quarter of 2021, just before the Supreme Court ruling, the company's quarterly prescriptions expanded to KRW 3.6 billion. Since most companies have Xarelto generics in stock, the expectation is that the two products will bring a synergistic effect. On the contrary, some believe that it is unlikely that these generics will be able to achieve similar levels of prescription growth as Xarelto generics. As Xarelto generics are already well established in the DOAC market, it is unlikely that they will be able to generate the same level of prescriptions as expected. In addition, some believe that even if generic prescriptions of Eliquis do increase, this will then lead to a decline in Xarelto generic sales.
- Policy
- 3-way race starts in faslodex mkt with new generic entry
- by Lee, Tak-Sun Feb 03, 2025 05:52am
- Breast cancer treatment A new generic company entered the fulvestrant drug market that has been a battle between the original’s owner AstraZeneca and the first generic developer Boryung. The new entrant, Korus Pharm, will spark three-way competition in the market with its product being reimbursed this month. According to industry sources on the 31st, Korus Pharm’s breast cancer treatment, ‘Elbracan Inj (fulvestrant ) will be reimbursed from this month. The original fulvestrant is AstraZeneca’s Faslodex Inj, which was released in 2008 in Korea. The competition started after Boryung first released the generic version, ‘Fulvet Inj.’ in 2022. Elbracan, which is being released this time, differs from the other two and the fact that it is manufactured domestically. Elbracan is manufactured at Korus Pharm’s Chuncheon manufacturing plant. On the other hand, Faslodex Inj and Fulvet Inj. are imported finished drugs. Another point is the difference in the drug price. Elbracan’s price has been adjusted to 53.55% of the highest insurance price, which is KRW 288,194 per pack. On the other hand, the premium pricing term for Faslodex and Fulvet has been extended and has not yet been reduced to the level of 53.55%. The premium pricing benefit is scheduled to end in August this year. As a result, the price of Faslodex has remained at 70% of the original first-year price, at KRW 376,724 since the generic’s entry. The price of Boryung’s Fulvet has been maintained at KRW 357,888 with the innovative pharmaceutical company premium. The Elbracan listed this time is about KRW 80,000 to 90,000 cheaper, so it will be interesting to see how the lower price will affect the market competition in the early stages of its entry. Meanwhile, the launch of the generic product Ibrance (Palbociclib) that is used in combination with Faslodex is expected to intensify the onslaught of domestic generic products in the Faslodex-Ibrance combination market as Kwangdong Pharmaceutical and Daewoong Pharmaceutical have been granted approval for their respective Ibrance generic products. Boryung has also been expanding its portfolio of breast cancer treatment drugs, including last year signing a contract with Bixink Therapeutics to jointly market and sell the breast cancer drugs Nerlynx (neratinib) and Fulvet (fulvestrant).
- Company
- ROS1 targeted cancer drug 'Augtyro' nearing mkt entry
- by Eo, Yun-Ho Feb 03, 2025 05:52am
- Product photo of Augtyro (repotrectinib)The ROS1-targeting anticancer drug, 'Augtyro,' is expected to be commercialized in South Korea. According to industry sources, Bristol Myers Squibb (BMS) Korea is close to receiving approval from the Ministry of Food and Drug Safety (MFDS) for Augtyro (repotrectinib), an anticancer drug that can be used regardless of cancer types. This drug was designated as an orphan drug from the MFDS in early June 2024. This drug was indicated for ▲the treatment of patients with ROS-1 positive topical advanced or metastatic non-small cell lung cancer (NSCLC) ▲the treatment of patients with NTRK(Neurotrophic tyrosine receptor kinase) fusions in topical advanced, metastatic solid cancer or who have a high likelihood of severe morbidity upon surgical removals. Augtyro initially received U.S. FDA approval for the treatment of NSCLC in November 2024. Its indication for the treatment of solid cancer accompanying NTRK fusions was recently approved. In November of the same year, it also successfully received a recommendation for marketing authorization from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The drug’s efficacy was confirmed through multinational Phase 1/2 TRIDENT-1 studies. The results showed that 71 patients who had not previously received TK1 treatments had an objective response rate (ORR), which was the primary endpoint, of 79% after Augtyro treatment. Progression-free survival (PFS) doubled compared to conventional targeted therapy. The ORR was defined by the percentage of patients showing decreased tumor sizes (partial response) or no more cancer symptoms (complete response) during the specified treatment period. The median duration of response (DOR) was 34.1 months. 56 patients who had previously undergone ROS1 TK1 therapy and no chemotherapy had an ORR of 38% and a median DOR of 14.8 months. The study also demonstrated the drug’s effectiveness in patients who had developed drug tolerance to previously administered targeted therapies. 56 patients with drug tolerance had an ORR of 38% and a PFS of 9 months. Notably, 17 patients who acquired G2032R mutation had an ORR of 59% and a PFS of 9.2 months. The TRIDENT-1 study was published in the New England Journal of Medicine (NEJM, IF 176.082) with Byoung Chul Cho (Director of the Lung Cancer Center at Yonsei Cancer Hospital) as the corresponding author. Meanwhile, lung cancers with ROS1 mutation account for 2% of all lung cancers. Conventional therapy includes targeted anticancer therapies that target the mutated gene. The common drugs are 'crizotinib' and 'entrectinib.' 'Repotrectinib' is gaining attention as the next-generation drug.
