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- Company
- Qarziba may be prescribed in general hospitals in KOR
- by Eo, Yun-Ho Apr 3, 2025 05:55am
- Qarziba, an immunotherapy drug that targets neuroblastoma, may now be prescribed at general hospitals in Korea. According to industry sources, Recordati Korea's immunotherapy drug for high-risk, recurrent, and refractory neuroblastoma, Qarziba Inj (dinutuximab beta), has passed the drug committees (DCs) of the ‘Big 5 general hospitals’ in Korea, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, and Severance Hospital. The company has been expanding the drug’s prescription in Korea since receiving reimbursement listing in December last year. As the first drug covered through the approval-evaluation-negotiation linkage system, the drug was approved only 13 months after it was approved in Korea. According to the Ministry of Health and Welfare notice, children from 12 months or older to less than 20 who have not received anti-GD2(disialoganglioside2) antibody treatment before with ▲high-risk neuroblastoma (INSS stage 4 disease or stage 2-3 and have MYCN gene amplification’ and have shown partial or better response to induction chemotherapy and have had hematopoietic stem cell transplant and initiated within 6 months of the transplant, and ▲recurrent or refractory neuroblastoma may receive Qarziba with reimbursement. The drug demonstrated its effect through major pivotal studies, including the Phase III APN311-302 trial. Main results showed that the 5-year event-free survival (EFS) rate for the Qarziba treatment group (378 patients) among high-risk neuroblastoma patients recieivng maintenance therapy was 57%, and the five-year overall survival (OS) rate was 64%, which was statistically significantly higher than that of the control group (466 patients) that did not receive Qarziba immunotherapy., which was 42% and 50%, respectively. Ji-won Lee, a professor of the Department of Pediatric Hematology-Oncology at Samsung Medical Center, said, “This disease has a particularly poor prognosis and a large disease burden, so it is very important to implement an appropriate maintenance therapy that can minimize minimal residual disease (MRD) to prevent recurrence when treating neuroblastoma. Qarziba has significantly improved the survival of patients with high-risk neuroblastoma as maintenance therapy compared to those that did not receive maintenance immunotherapy, shifting the treatment paradigm.” “Major overseas guidelines, such as the International Society of Pediatric Oncology Europe Neuroblastoma (SIOPEN) and the National Comprehensive Cancer Network (NCCN), have already recommended anti-GD2 antibodies such as Qarziba as standard maintenance immunotherapy for high-risk neuroblastoma,” said Jung-yoon Choi, Professor of the Department of Pediatrics at Seoul National University Children's Hospital. ”With the Korean patients also able to receive the global standard of care, I believe this will change the treatment environment in Korea.”
- Company
- "COVID-19 differs from influenza…vaccination essential"
- by Whang, byung-woo Apr 3, 2025 05:55am
- "COVID-19 can lead to 'long COVID,' and its progression tends to be more severe among the elderly and immunocompromised individuals. It is crucial to emphasize COVID-19 prevention as the saying goes, 'an ounce of prevention is worth a pound of cure.' After the announcement of the endemic in 2023, COVID-19 has repeatedly mutated, thus regarded as becoming a 'resident virus' that makes a comeback similar to influenza. Although determining the exact seasonal pattern of COVID-19 may require more time, the government provides vaccination to high-risk groups, such as individuals aged 65 and older. During a meeting with Daily Pharm, Dr. Woo Joo Kim, a professor in the Department of Infectious Diseases at Korea University Guro Hospital, emphasized the importance of reducing the disease burden by putting efforts into increasing the COVID-19 vaccination rate. Currently, the legal status of COVID-19 has been designated as a class 4 infectious disease in South Korea after the endemic announcement in 2023. Like influenza, COVID-19 is categorized as an infectious disease requiring daily monitoring. Despite the initial expectation that COVID-19 will show seasonal spikes, it has not demonstrated a clear seasonal pattern like influenza. Dr. Kim explained, "COVID-19 is likely in a 'transition period.' The severity is lowered compared to the earlier phase of the pandemic due to vaccination, but it is yet to be defined as a seasonal virus," adding, "In the past few years, COVID-19 made a comeback in around January-February and around August. However, it is yet too soon to generalize." "Over the past four years, the severity of COVID-19 has diminished compared to its early phase, thanks to immunity acquired through vaccination and natural infection. However, high-risk groups, including the elderly, individuals with underlying conditions, immunocompromised patients, pregnant women, and residents of long-term care facilities, continue to face a significant burden of disease, with a high risk of severe illness or death," Dr. Kim said. Dr. Kim's attention to the COVID-19 vaccine during this transitional period is because COVID-19 exhibits infection characteristics distinct from those of influenza. While both diseases may be perceived as similar, there are clear differences in infection patterns, causative pathogens, and complications. The influenza virus causes influenza, whereas COVID-19 is caused by SARS-CoV-2. "The COVID-19 virus not only targets the respiratory system but also invades the vascular system, kidneys, and other organs, causing a systemic infection with higher severity and fatality rates," Dr. Kim stated. "Long COVID, affecting the entire body as a sequela, can occur, and its impact tends to be more severe in older individuals or those with weakened immune systems." Although COVID-19 and influenza share similar symptoms and some complications, which can lead to them being conflated, experts warn that this may result in the risks of COVID-19 being underestimated, calling for heightened vigilance." For these reasons, the government is currently administering COVID-19 vaccines to high-risk groups, including individuals aged 65 and older, immunocompromised persons aged at least 6 months, and residents of facilities vulnerable to infections, to prevent severe illness and death. The ongoing issue is whether to include the COVID-19 vaccine in the National Immunization Program (NIP). There is a growing consensus that incorporating the COVID-19 vaccine into the NIP is essential to boost vaccination rates for the currently administered vaccines." Dr. Kim said, "In addition to preventing infections, hospitalizations, and deaths at the individual level, incorporating the COVID-19 vaccine into the NIP is essential for sustaining our national population. For instance, by systematically benchmarking the well-established NIP for the influenza vaccine in individuals 65 and older, we can effectively plan and implement a similar strategy for the COVID-19 vaccine." There is ongoing concern about determining the optimal vaccination schedule, as it remains difficult to predict the precise timing of the COVID-19 surge. Dr. Kim emphasized, "When establishing the vaccination schedule for the COVID-19 vaccine, it is crucial to base decisions on scientific evidence regarding the outbreak period, the duration of antibody persistence, and the vaccine's ability to counter emerging variants." He advised, "Antibodies may not form adequately or may quickly be depleted in individuals with severe immunocompromise. It is advisable to tailor the dosing frequency and timing based on each patient's immune status." Dr. Kim added, "High-risk groups such as immunocompromised individuals and residents of long-term care facilities face a significantly higher risk of severe illness if infected, yet their vaccination rates remain low. If we were to improve COVID-19 vaccination rates, government's promotional activities is essential." "COVID-10 vaccination can be compared to wearing a seat belt, lowering severity" Currently, two mRNA COVID-19 vaccines are available in Korea. Aside from a minor difference in antigen dosage (approximately 30 to 50 micrograms) their basic compositions, including encapsulation in lipid nanoparticles, are virtually identical. In clinical practice, healthcare providers typically use whichever vaccine is distributed to their institutions and available for immediate use. However, due to differences in domestically imported volumes, over 80% of vaccinations administered during 2023&8211;2024 were Pfizer's Comirnaty. In global Phase 3 trials, Comirnaty demonstrated a 95% preventive efficacy across COVID-19&8211;na&239;ve and previously infected participants, with overall safety profiles remaining favorable. Dr. Kim explained, "mRNA vaccines like Comirnaty induce a robust T-cell immune response, ensuring that the benefits of preventing severe disease and death are sustained over a long period. The Korea Disease Control and Prevention Agency also strongly emphasizes these outcomes when recommending COVID-19 vaccination." One of the concerns raised about COVID-19 vaccines has been safety issues that emerged during the pandemic. However, Dr. Kim believes that confidence in the vaccine's safety has increased. He noted, "Among high-risk groups such as those aged 65 and older or individuals with underlying conditions, no significant adverse reactions have been observed, and the benefits of vaccination are substantially greater," adding, "With sufficient vaccination experience now accumulated and those who experienced adverse reactions subsequently excluded from further dosing, the incidence of adverse events in recent vaccination cohorts is very low." He particularly compared vaccination to wearing a 'seat belt.' Although wearing a seat belt can be uncomfortable and does not guarantee 100% prevention of injuries, it significantly reduces the risk when an accident occurs. Similarly, COVID-19 vaccination is essential to lower the risks of infection and severe disease. Lastly, Dr. Kim stressed that a coordinated effort at the individual, societal, and government levels remains critical for effective COVID-19 management. Dr. Kim said, "High-risk groups, such as the elderly and those with underlying conditions, must recognize their risk of infection and proactively get vaccinated, and if they experience symptoms, they should promptly seek diagnosis and treatment," adding, "I believe including the COVID-19 vaccine in the NIP can be expedited if individuals actively voice their concerns." "On a societal level, we need to foster a 'take a break when you're sick' culture, and at the government level, it is essential to establish an independent monitoring system solely for COVID-19," Dr. Kim added. "The government must quickly set vaccination schedules and develop promotional strategies based on up-to-date data on the latest COVID-19 outbreak patterns, disease burden, and the efficacy and safety of vaccines."
- Opinion
- [Reporter's View] Preparations for US pharmaceutical tariff
- by Kim, Jin-Gu Apr 3, 2025 05:55am
- US President Donald Trump designated April 2 (local time) as 'America's Day of Liberation.' The day the US will announce reciprocal tariff rates for various countries. US reports expect details on tariff-affected countries, rates, and applicable product categories to be disclosed as early as the evening of the 1st. The specific tariff rates will be known in South Korea by the morning of the 2nd or, at the latest, the morning of the 3rd in Korean time. The United States is Korea's largest market for pharmaceutical exports. Last year, Korean pharmaceutical exports to the US reached US$1.359 billion (approximately KRW 2 trillion), a 50% increase compared to 2023. When expanded to include the broader market, exports have surged from US$33 million a decade ago in 2014 to over 40 times that amount. The US accounted for 18% of Korea's total pharmaceutical export revenue last year, making it the largest single market among all countries. This fact underscores why US tariffs on pharmaceuticals could have a significant impact. Industry attention is now focused on whether Korean pharmaceuticals will also be subject to tariffs, and if so, which specific drugs and at what rates. A 25% tariff rate is the most likely scenario. During a press conference on March 18, President Trump even hinted that pharmaceutical tariffs 'could be 25% or more.' However, it remains unclear whether the forthcoming reciprocal tariff announcement scheduled for April 2 will include pharmaceuticals, or if tariffs on pharmaceuticals will be imposed separately. Some analysts predict that pharmaceuticals might be excluded from the tariff measures, arguing that imposing tariffs on them would likely lead to a surge in domestic healthcare costs. Indeed, recent projections indicate that the number of drugs experiencing supply shortages in the US could exceed 215 (up from 127), and US generic drug prices may increase by an average of 18%. One report even warned that US healthcare spending could skyrocket from a baseline of 5% to as high as 60%. Another opinion suggests that tariffs could be applied only selectively, targeting certain countries with large trade deficits, such as some European nations, or excluding critical categories like essential or supply-shortage drugs. Nonetheless, prevailing forecasts still lean toward the imposition of pharmaceutical tariffs. Should tariffs be levied on domestically produced drugs, it could deliver a severe hit to Korea's pharmaceutical and biotech industries. Companies are left with few options and must concentrate on creating exit strategies. The Trump administration has reiterated a 'tariff first, negotiate later' approach. Even if tariffs are eventually imposed on Korean pharmaceuticals, there remains potential to mitigate the impact through subsequent negotiations. Despite South Korea being identified as a 'notorious trade imbalanced country,' industry negotiators argue that it is important to emphasize that Korea has consistently run a trade deficit with the US in the pharmaceutical sector. In the medium to long term plan, South Korea must also accelerate reforms in its drug pricing and innovative pharmaceutical company certification systems. The United States Trade Representative (USTR) has previously released a report stating that Korea's drug pricing policies and innovative pharmaceutical company certification system disadvantage foreign companies. Both systems are currently undergoing revisions, and if given the opportunity to negotiate with the US, South Korea should actively highlight these improvements at the bargaining table.
- Company
- J&J MedTech launches PFA Varipulse platform
- by Whang, byung-woo Apr 3, 2025 05:54am
- Johnson & Johnson MedTech announced on the 1st that it will launch the Varipulse platform, an arrhythmia treatment solution that uses three-dimensional pulsed field ablation (PFA), in Korea. As the most common arrhythmia in the world, Atrial fibrillation (AFib) is a condition in which the atria beat irregularly and rapidly. In particular, the prevalence of atrial fibrillation in Korea is on the rise with the aging population. According to the Korean Heart Rhythm Society, the incidence of this disease has increased by about 1.5 times in the last 10 years, and about 1 million people are suffering from atrial fibrillation in Korea. The Varipulse platform is the first 3D pulsed field ablation treatment solution in Korea developed for the treatment of drug-refractory paroxysmal atrial fibrillation. PFA has recently gained attention as a treatment for atrial fibrillation and is an innovative treatment that reduces the side effects of conventional radiofrequency ablation and cryoballoon ablation. PFA uses an electric field (pulse field) to selectively remove lesion tissue that causes arrhythmia, minimizing damage to surrounding normal tissue and shortening procedure time and patient recovery time. Currently, Varipulse is the only PFA solution introduced in Korea that has been developed based on a three-dimensional cardiac mapping (3D mapping) system. The technology creates a precise three-dimensional image of the anatomical structure of the left atrium and allows the catheter to be accurately tracked in real-time. The size of the Varipulse Catheter can be adjusted to fit each patient's heart anatomy, allowing for an optimized procedure fit for each patient's heart shape. Also, the Varipulse platform can minimize patient radiation exposure by integrating a 3D cardiac structure mapping function with intracardiac echocardiography (ICE) to provide real-time images of the heart during PFA therapy. These innovative features are expected to shorten procedure time and significantly improve patient treatment outcomes. “We are pleased to be able to hasten the introduction of the innovative PFA treatment with Varipulse to many atrial fibrillation patients in Korea, following in the United States, Europe, Japan, China, and Canada. We expect that the launch of Varipulse will contribute to the improvement of atrial fibrillation patients and treatment in Korea,” said Jinyong Oh, Managing Director of Johnson & Johnson MedTech's North Asia region Oh added, “We will continue to work on fostering a patient-centric treatment environment and introduce innovative solutions to contribute to the development of Korea’s medical field.” Meanwhile, Johnson & Johnson MedTech established a medical technique education center for the treatment of cardiac arrhythmia at its Yongsan headquarters in Seoul last year, providing education and training to healthcare professionals on procedures related to the treatment of arrhythmia.
- Company
- Korea's drug pricing system on US tariff on pharmaceuticals
- by Kim, Jin-Gu Apr 2, 2025 05:56am
- As the Trump administration's tariff against the world will go into effect immediately, a report has been released alleging that Korea's drug pricing and innovative pharmaceutical company certification policies are being unfairly imposed in the United States. According to the KoreaBIO on the 1st, the United States Trade Representative (USTR) issued a report on trade barriers affecting 59 major exporting countries on March 31. A notable section of the report focuses on Korea's policies for pharmaceuticals and medical devices, arguing that Korea's drug pricing, reimbursement, and innovative pharmaceutical company certification policies function as trade barriers in the U.S. The report criticized "Korea's drug pricing and reimbursement policies lack transparency. Stakeholders do not get sufficient opportunity to offer substantive input during policy changes." Regarding the innovative pharmaceutical company certification policy, the report said, "While certain companies receive benefits such as tax credits, R&D support, and preferential pricing, no explanations are provided to companies denied certification," adding, "The United States calls on South Korea to enhance transparency and ensure that stakeholders have opportunities to express their views." These criticisms are similar to those raised earlier this year by the U.S. pharmaceutical industry association PhRMA. PhRMA said, "The value of innovative American drugs is not adequately recognized in Korea. Korean pricing agencies often rely on outdated cost-effectiveness thresholds, and the evaluation process suffers from limited transparency and predictability." These criticisms are similar to those raised earlier this year by the U.S. pharmaceutical industry association PhRMA. PhRMA said, "The value of innovative American drugs is not adequately recognized in Korea. Korean pricing agencies often rely on outdated cost-effectiveness thresholds, and the evaluation process suffers from limited transparency and predictability." Further stating, "It violates both the obligation for fair treatment of domestic industries and the spirit of the Korea-US FTA." On April 2 (local time), the Trump administration announced that it would officially announce reciprocal tariffs on major trading partners, including South Korea. President Donald Trump announced, "The results could be revealed as early as the evening of the 1st or 2nd." South Korea's pharmaceutical and biotech industries are closely monitoring this development. Korea’s pharmaceutical and biotech industry is recording a trade deficit against the United States. However, concerns are mounting that companies exporting pharmaceuticals to the U.S. could face significant setbacks if tariffs above a certain threshold are imposed. Moreover, reciprocal tariffs are imposed due to perceptions that Korea's innovative pharmaceutical company certification, pricing, and reimbursement policies are unfair. There will likely be increased pressure to reform these systems. In response, the Ministry of Health and Welfare (MOHW) has recently revised the certification criteria for innovative pharmaceutical companies, introducing separate certification categories for global pharmaceutical companies. The MOHW plans to make these improvements by September.
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