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- 2026-03-10 17:54:56
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- "Winrevair, gamechanger for pulmonary arterial hypertension"
- by Whang, byung-woo Aug 18, 2025 06:01am
- Winrevair (sotatercept), a new mechanism treatment for pulmonary arterial hypertension that has emerged after over 20 years, has been approved in Korea. Consequently, competitive market is expected. Although reimbursement remains a challenge, it is expected to change the treatment paradigm for pulmonary hypertension, a disease with significant unmet needs, by addressing the fundamental cause of the disease. Dr. Wook-Jin Chung, President of the Korean Society of Pulmonary HypertensionMSD Korea held a press conference on August 12, celebrating the approval of Winrevair and highlighting the drug's role and value. Pulmonary hypertension is not simply a state of constricted blood vessels. It is a disease of structural narrowing where the walls of the pulmonary arterioles thicken and their lumens become constricted, making it different from general hypertension. Dr. Wook-Jin Chung, President of the Korean Society of Pulmonary Hypertension (Professor of Cardiology at Gachon University Gil Medical Center), explained, "Pulmonary hypertension patients suffer from shortness of breath, cough, fatigue, and fainting as the disease advances. However, due to a complex diagnostic process, patients experience a diagnostic odyssey that can take up to three years." "Pulmonary hypertension patients experience such severe shortness of breath that even walking becomes difficult, leading to serious limitations in all aspects of daily life, including exercise, childcare, housework, and social activities. In severe cases, it can be fatal, with a risk of sudden death." For high-risk patients, the probability of death within one year exceeds 20%, and approximately 30% of domestic patients still die within five years of diagnosis. Until now, phosphodiesterase-5 (PDE5) inhibitors and calcium channel blockers (CCBs) have been used, but they have only been effective in controlling symptoms. Dr. Chung said, "Pulmonary hypertension is both a rare, intractable disease and a chronic condition, so there was an urgent need for a treatment strategy that could restore a healthy daily life to patients." In relation to this, the newly approved Winrevair is generating high expectations because it approaches the fundamental cause of the disease. Winrevair is the first-in-class Activin Signaling Inhibitor (ASI), utilizing the 'Activin' pathway, which is one of the pathogenic mechanisms of pulmonary hypertension. This treatment demonstrates the potential for reverse remodeling by inhibiting the proliferation of abnormally thickened blood vessels, thereby reversing the remodeling of pulmonary arterioles and the right ventricle. In a study of 323 pulmonary hypertension patients, the Winrevair group's 6-minute walk distance (6MWD) increased by 40.1 m, while the placebo group's decreased by 1.4 m. Additionally, Winrevair reduced the risk of clinical worsening or death from all causes related to pulmonary hypertension by 84%. Kyung-hee Kim, Chairperson of the Clinical Guidelines Committee of the Korean Society of Pulmonary Hypertension, said, "Experts from the clinical guidelines committees in Europe and the United States have recommended the addition of ASI when updating pulmonary hypertension treatment guidelines," and added, "The Korean Society of Pulmonary Hypertension is also reviewing the inclusion of ASI in the pulmonary hypertension treatment guidelines in Korea." Dr. Kyung-hee Kim, Chairperson of the Clinical Guidelines Committee of the Korean Society of Pulmonary HypertensionWinrevair was approved through the Ministry of Food and Drug Safety's 'Concurrent Approval-Evaluation-Negotiation Pilot Program' and has quickly entered the reimbursement review process. The Ministry of Health and Welfare (MOHW) has been running the 'Concurrent Approval-Evaluation-Negotiation Pilot Program' since 2023 to improve access to treatment for life-threatening, severe, and rare diseases. The project conducts approval, reimbursement evaluation, and drug price negotiations simultaneously, aiming to shorten the time required for new drugs to be included in the National Health Insurance list. Dr. Chung emphasized, "For patients to benefit from Winrevair, it must be quickly covered by national health insurance." He added, "Even if the treatment is expensive, and its efficacy has been proven overseas, efforts are necessary to ensure it can be used, even if strict criteria are applied."
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- Imfinzi denied reimb for bile duct cancer for the 3rd year
- by Eo, Yun-Ho Aug 14, 2025 06:13am
- Attention is focused on whether there will be progress in the reimbursement process for Imfinzi for bile duct cancer, which has remained non-reimbursed for three years now. According to industry sources, the Health Insurance Review and Assessement Service's Drug Reimbursement Evaluation Committee may likely review the agenda of expanding the reimbursement of AstraZeneca Korea's PD-L1 inhibitor immunotherapy Imfinzi (durvalumab) for bile duct cancer in the second half of the year. In the harsh environment of bile duct cancer, where the average survival period was just over seven months, the emergence of Imfinzi brought about a change in the treatment landscape. Imfinzi demonstrated more than a twofold improvement in overall survival rate compared to the standard chemotherapy regimen at the three-year mark, and in a subgroup analysis of Korean patients, it proved to provide even better survival benefits than the overall patient population. Countries such as Canada, the United Kingdom, Australia, Japan, and Taiwan quickly reimbursed Imfinzi in recognition of its clinical innovation. In the case of the United Kingdom, considering the poor reality of bile duct cancer treatment and the fact that Imfinzi is the first first-line treatment for bile duct cancer, the ICER threshold was applied flexibly by exceptionally weighting the quality-adjusted life years (QALY) during the pharmacoeconomic evaluation process. However, in South Korea, reimbursement barriers remain, limiting patients' access to treatment. It has been three years since Imfinzi was approved by the Ministry of Food and Drug Safety as a first-line treatment for metastatic bile duct cancer. The indication for bile duct cancer was approved by the Cancer Review Committee in November 2024, but there has been no significant progress to date. Jung-yong Hong, Professor of Hematology and Oncology at Samsung Medical Center, said, “The ultimate goal of the government, pharmaceutical companies, and medical professionals is to provide Imfinzi’s treatment benefits, proven as standard therapy, to bile duct cancer patients as quickly as possible. Measures to strengthen institutional flexibility must be explored to enhance treatment access for bile duct cancer patients.”
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- "A paradigm shift in atopic dermatitis treatment"… Adtralza
- by Whang, byung-woo Aug 14, 2025 06:13am
- The treatment landscape is undergoing significant changes as new drugs for atopic dermatitis, including biologics and JAK inhibitors, have emerged over the past few years. Experts assess that patients who gave up on receiving treatments due to recurrence and side effects are revisiting hospitals with the introduction of new drugs. As treatment options become diverse, the primary concern for the clinical field is 'what' treatment to use. During the meeting with DailyPharm, Professor Seong Jun Seo of Soon Chun Hyang University Cheonan Hospital's Department of Dermatology emphasized the importance of personalized treatment tailored to each patient, along with consideration of economic factors. More treatment options to treating atopic dermatitis…"personalized treatment is key" Atopic dermatitis treatment options have expanded beyond the previous standard therapies, which include moisturizers and topical steroids, to two types: biologics and oral JAK inhibitors. Currently, three biologics and a JAK inhibitor are listed for reimbursement in Korea. Professor Seong Jun Seo of Soon Chun Hyang University Cheonan HospitalProfessor Seo advises that personalized treatment, based on patient characteristics, is key as treatment options continue to expand. Professor Seo said, "In my opinion, criteria for selecting a treatment should be based on the patient's condition and needs, and that 'the best drug should be the first one used'," and stressed, "It is crucial to provide the best treatment option for each patient from the very beginning." For example, for patients with atopic dermatitis who also have other allergic conditions (such as asthma or rhinitis), or those who are elderly or have chronic diseases, a biologic with a lower burden on the systemic immune system is considered first. In contrast, for patients who desire a quick effect or have a strong fear of injections, an oral JAK inhibitor is used first. This means that a personalized treatment, which considers both treatment goals and patient preferences, is key to treatment success. However, in reality, insurance criteria are a stumbling block. Under the current National Health Insurance's Special Case Medical Expense Coverage criteria, new drug treatment is limited to severe patients (EASI score ≥23, BSA ≥10%). This leaves moderate patients in a reimbursement blind spot, and experts unanimously agree that this needs to be improved to widely support personalized treatment. Professor Seo also pointed out that "more flexible criteria are needed, such as giving weighted scores to lesions on areas that significantly affect quality of life, like the face and neck, even if the EASI score is below 23." One Year After Adtralza's Launch…Patients are more satisfied with improved safety and facial flusing In this situation, the evaluation from the field is that Adtralza (tralokinumab) from LEO Pharma, which was the second biologic to be listed in Korea, is gaining favor with many patients since its launch last year. Adtralza, which has an IL-13 single-target mechanism that selectively targets only interleukin-13, was noted as a strong competitor to the existing Dupixent (which has an IL-4/13 dual-target mechanism). In clinical trials, Adtralza achieved an EASI-75 score in 56% of patients at week 16, demonstrating its superior efficacy compared to placebo. It also showed a 38.9% achievement rate for an IGA score of 0/1 (almost clear of lesions). Adtralza was listed for health insurance reimbursement in May 2024. In its first year, it has successfully established itself in the prescription lists of university hospitals, rapidly expanding its market share. What are Adtralza's unique strengths, then? Professor Seo, who has prescribed various treatments in the clinical setting, highlighted Adtralza's excellent safety profile. Professor Seo explained, "Dupixent generally has high satisfaction due to its excellent efficacy and low side effects, but its drawbacks include unexpected side effects like conjunctivitis and facial flushing," and added, "While Adtralza can also cause conjunctivitis, the incidence is lower than with Dupixent, and it shows an effect in improving symptoms in patients who experienced facial flushing with Dupixent." As improvement of symptoms in exposed areas is directly related to a patient's quality of life, Adtralza could be a favorable option to reduce the disease burden for atopic dermatitis patients who experience social avoidance due to severe inflammation on their face or neck. Patient A, who was present with Professor Seo, said, "After being treated with Adtralza, my symptoms improved noticeably over time. I took it for about half a year after the initial dose and felt a clear treatment effect." Another strength is its cost-effectiveness. Regarding this, Professor Seo said, "Adtralza's drug price is lower than that of other biologics. It's about 60% of Dupixent's cost, which makes it a preferred option for patients with a significant financial burden." Given the long-term nature of atopic dermatitis treatment, the cost of medication is a concern for both patients and medical professionals. In terms of cost-utility, Adtralza's superior accessibility is notable. Limitations of inter-class switching…highlighted biomarker importance With the increasing number of new treatment options, the project of creating an environment that benefits patients is gaining prominence. This year, in response to requests from the field, the government partially relaxed reimbursement criteria to allow inter-class switching between biologics and JAK inhibitors. However, the lack of a provision for changing within the same class remains a point of regret. Professor Seo said, "Atopic dermatitis is a complex disease with various contributing factors, so a more flexible insurance application is needed for treatment selection," and added, "The symptom patterns and patient responses can vary, so when one drug is insufficient, a path should be opened to allow switching to a different drug within the same class." Lastly, Professor Seo emphasized the importance of biomarker development for the future of atopic dermatitis treatment. He explained that although symptoms can now be suppressed for long periods with available therapies, personalized indicators are necessary to establish precision medicine. Professor Seo added, "Atopic dermatitis is a difficult disease that requires long-term management, but with recent treatment innovations, it is becoming a manageable chronic disease." He concluded, "To implement precision medicine, we need personalized indicators for each patient, and when predictive treatment technologies are introduced in the future, we can take another step closer to curing atopic dermatitis."
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- Only Vemlidy’s sales grew in the ₩300B HBV drug mkt
- by Kim, Jin-Gu Aug 14, 2025 06:13am
- Korea's hepatitis B treatment market, which is valued at KRW 300 billion annually, is rapidly restructuring around Vemlidy (tenofovir alafenamide). Among original products, only Vemlidy is maintaining its growth, and in the generic market, only the Vemlidy series has shown a significant increase in sales. HBV treatment market reaches KRW 150.9 billion in 1H, up 2% year-on-year According to the pharmaceutical market research institution UBIST on the 13th, the domestic hepatitis B treatment market reached KRW 150.9 billion in the first half of this year. This represents a 2% increase from the KRW 147.6 billion in the first half of last year. At this pace, the HBV drug market is expected to record prescription sales of over KRW 300 billion for the second consecutive year. Share of Vemlidy original and generic products in the Quarterly HBV treatment market Last year, the hepatitis B treatment market re-entered the KRW 300 billion range for the first time in 6 years since 2018. The market had exceeded KRW 300 billion in 2018 but decreased to KRW 273.1 billion in 2019. This was due to the expiration of the patent for Gilead Sciences' Viread, which had been leading the market, and the subsequent price reduction of the drug. The market further shrank to KRW 266 billion in 2020. Since 2021, the market has shifted to growth. In 2021, the market increased by 4% to KRW 275.6 billion. In 2022, it reached KRW 283.8 billion, then grew by 3% for two consecutive years to KRW 283.8 billion in 2022, then KRW 292.3 billion in 2023. Last year, it expanded further to over KRW 300 billion. Vemlidy becomes the only original drug to show growth…grows 10% in one year Gilead's Vemlidy drove market growth. Vemlidy’s first-half prescription sales reached KRW 37.8 billion, a 10% increase from the previous year. Vemlidy is a new hepatitis B drug developed by Gilead as a successor to Viread. While the existing Viread is highly effective in suppressing the hepatitis B virus, its drawbacks include side effects such as renal dysfunction and reduced bone density. Vemlidy overcomes these limitations of Viread. In clinical trials, no such side effects were observed. Given the challenging nature of hepatitis B, which is difficult to cure, the long-term safety of Vemlidy has emerged as a key advantage. Quarterly prescriptions of major HBV treatments (Viread, Baraclude, Vemlidy) Launched in Korea in 2017, Vemlidy is the only original product among major products that has maintained growth. Meanwhile, the market leader, Viread (tenofovir sofosbuvir), saw a 1% decrease from KRW 45.4 billion to KRW 44.9 billion in one year. Sales of BMS's ‘Baraclude (entecavir)’ decreased by 1% from KRW 35.3 billion to KRW 35.1 billion. In addition, ‘Zeffix (lamivudine)’, ‘Besivo (besifovir)’, ‘Levovir (clevudine)’, and ‘Sebivo (telbivudine)’ all saw a decrease in prescriptions. Hepsera (adefovir) has been completely withdrawn from the market since 2023. Among the major products, while Viread and Baraclude saw a slowdown, Vemlidy was the only one to show an increase in its prescription sales, leading to changes in the market rankings. Vemlidy ranked third in the market behind Viread and Baraclude until the first half of last year, but then surpassed Baraclude to move up to second place. The gap with Viread narrowed from KRW 11 billion to KRW 7.2 billion in just one year. Generic market also sees rapid growth of Vemlidy follow-on drugs... accelerates market restructuring The same trend has been observed in the generic market. Vemlidy generics are the only ones that showed continued growth. The combined prescription amount for Vemlidy generics in the first half of this year was KRW 4.1 billion, more than double the KRW 2 billion recorded in the same period last year. Although it showed a somewhat sluggish trend initially after its official launch in February 2023, its growth has accelerated since last year. Sales of Samil Pharmaceutical's ‘Vemlino’ increased from KRW 9 billion in the first half of last year to KRW 18 billion in the first half of this year, while sales of Dong-A ST's ‘Vemlia’ increased from KRW 7 billion to KRW 13 billion, each more than doubling in sales. The remaining products also saw their prescription sales increase by more than twofold. On the other hand, Baraclude generics and Viread generics have seen a slowdown in their upward trend. The combined prescription sales of Baraclude generics decreased by 3% from KRW 16.3 billion to KRW 15.8 billion over the past year. Sales of Viread generics also decreased by 3% from KRW 7.2 billion to KRW 7 billion. The industry expects that the market restructuring centered on Vemlidy will accelerate in both the original and generic markets. This is because Bemliride has already been recommended as a first-line treatment by liver associations in the US, Europe, and South Korea. In South Korea, its reimbursement has been approved for the treatment of non-cirrhotic liver cirrhosis and liver cancer since 2022.
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- 'Tevimbra' applies for reimbursement for five indications
- by Eo, Yun-Ho Aug 13, 2025 06:07am
- Product photo of Tevimbra 'Tevimbra' is quickly expanding following its successful inclusion in the insurance reimbursement for esophageal cancer. BeOneMedicines Korea has been confirmed to have applied for reimbursement on the day of approval for five new indications for its PD-1 inhibitor immunotherapy Tevimbra (tislelizumab), which received additional approval in June. In April, Tevimbra became the first immunotherapy to receive reimbursement for esophageal cancer. Following this, it has added five new indications for solid tumors, including esophageal cancer, gastric cancer, and non-small cell lung cancer. The specific expanded indications are ▲first-line combination therapy for unresectable, locally advanced, or metastatic esophageal cancer ▲first-line combination therapy for unresectable or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma ▲two types of first-line combination therapy, and second-line monotherapy for non-small cell lung cancer. Tevimbra has already received approval from the U.S. FDA for first- and second-line treatment of unresectable or metastatic esophageal squamous cell carcinoma, as well as for first-line treatment of advanced gastric cancer. The European Medicines Agency (EMA) has also approved it for first- and second-line treatment of esophageal squamous cell carcinoma, first-line treatment of advanced gastric cancer, and first- and second-line treatment of non-small cell lung cancer. Tevimbra is receiving various expanded indication in the global market. Since the company, BeOne Medicines, has been quick to proceed with reimbursement procedures for additional indications, Tevimbra's role is expected to expand across various cancer types in Korea. Expectations are particularly high due to BeOne Medicines' previous track record of successfully concluding negotiations with the government by advocating for 'reasonable drug pricing' since its initial listing. The reason for the low reimbursement rate by indication for immunotherapies, including esophageal cancer, is, as expected, related to drug pricing and financial burden. After reimbursement was applied to some cancer types, like lung cancer, the total amount claimed for immunotherapies and their share of the total cancer drug claims within the health insurance system significantly increased, raising concerns about the financial burden. As of 2023, cancer drug claims totaled KRW 2.4 trillion, with immunotherapy claims accounting for approximately KRW 500 billion, or 20% of the total cancer drug claims. It remains to be seen whether BeOne Medicines can uphold its company philosophy of 'providing innovative new drugs at a reasonable price and leaving no patient behind.' Meanwhile, the efficacy and safety of Tevimbra were proven in various indications through the RATIONALE clinical trial series (RATIONALE-303, 304, 305, 306, 307). In esophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma, Tevimbra demonstrated clinical benefits in the overall patient population. The trials showed consistent results in pre-specified subgroups based on PD-L1 expression.
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- Adult vaccination in a super-aged society highlighted
- by Whang, byung-woo Aug 13, 2025 06:07am
- South Korea has entered a super-aged society, with its population aged 65 and over exceeding 20%. The need for a response through adult vaccination is being emphasized. With the number of National Immunization Program (NIP) vaccines for adults limited to just influenza and pneumococcal vaccines, there is a growing opinion that the program needs to be expanded. The British Embassy in Seoul, the British Chamber of Commerce in Korea, and GSK Korea jointly hosted the '2025 Healthy Ageing Korea' forum on August 12 to discuss the necessity of adult vaccination. Professor Kwang-il Kim of the Department of Geriatrics at Seoul National University Bundang Hospital Professor Kwang-il Kim of the Department of Geriatrics at Seoul National University Bundang Hospital gave a presentation on 'Adult Vaccination for an Extended Healthy Lifespan'. Professor Kim emphasized the need for a full-lifecycle vaccination program as a healthcare policy to prevent infections and extend healthy lifespans in an aging society. Professor Kim stated, "While the consumption of medical resources and the social burden continue to increase among the elderly population in Korea, there are not many vaccines included in the National Essential Vaccination Program for adults, many of whom have chronic diseases that make them vulnerable to infectious diseases." In fact, NIP vaccines for adults are limited to two types: influenza and pneumococcal. Other adult vaccines are supported through small-scale vaccination projects using local governments' own budgets, leading to issues of fairness between regions. Professor Kim said, "Vaccination in the elderly can contribute to healthy aging by preventing disease-related complications, thereby reducing the medical burden and mortality rates." He added, "Diverse policy and strategic approaches to vaccination are needed for an aging society and healthy aging." Professor Hankil Lee of Ewha Womans University's College of Pharmacy gave a presentation on 'The Value of Adult Vaccination in Response to a Super-Aged Society', highlighting adult vaccination as a crucial public health policy for an aging population. According to Professor Lee, as the effectiveness of vaccination has been proven in the elderly, major overseas countries are including adult vaccination in their NIPs and supporting it with public funds. The UK offers free shingles vaccination for its elderly population, and Japan has been supporting shingles vaccines with a mixed financial structure since April of this year. Professor Hankil Lee of Ewha Womans UniversityProfessor Lee's opinion is that adult vaccination not only protects individuals from infectious diseases but also contributes to improving public health and reducing the socioeconomic burden at a national level, thereby generating economic effects from various perspectives. Professor Lee said, "In Korea, adult vaccination has not been fully recognized as a public good with sufficient social benefits from the perspective of responding to a super-aged society." He emphasized, "The policy gap in adult vaccination continues to exist, and it must be systematically addressed when establishing a comprehensive national vaccination plan in the future." The forum also revealed the results of a cost-benefit analysis of shingles and RSV (Respiratory Syncytial Virus) vaccines in adults in Korea. The analysis showed that for shingles vaccines in individuals aged 50 and over, the Return on Investment (ROI), or socioeconomic benefit relative to cost, was approximately 1.52. For RSV vaccines in the elderly aged 60 and over, the socioeconomic benefit was 1.65. Professor Lee said, "When the socioeconomic benefit exceeds 1, it is considered that a larger social benefit was generated than the cost incurred. This analysis proves that adult vaccination is a public investment that brings long-term socioeconomic benefits, going beyond just disease prevention." Colin Crooks, British Ambassador to the Republic of Korea, added, "While the elderly population is increasing globally, Korea is aging at a particularly fast pace." He continued, "In this situation, this forum was a meaningful opportunity for academia, the government, and the elderly community to discuss the protection of the health rights of the elderly and the necessity of prevention. It is expected to be an opportunity to raise awareness of the importance of prevention-centered public health across society."
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- Tariff impact inevitable for biodrugs’ export to the US
- by Cha, Jihyun Aug 12, 2025 06:16am
- Exports of domestically produced biopharmaceuticals to the US more than doubled last year compared to the previous year. If the Trump administration's tariffs on pharmaceuticals are implemented, the domestic biopharmaceutical export industry is expected to suffer significant damage. According to the “Key Data on the Domestic Biopharmaceutical Industry 2025” published by the Korea Biomedicine Industry Association (KoBIA, President: Jeong-seok Lee) on the 11th, last year's exports of domestically produced biopharmaceuticals to the United States reached USD 686.7 million (approximately KRW 845.9 billion). This represents a 103% increase from the previous year's USD 300.72 million (approximately KRW 417.8 billion). Last year, the export value of domestically produced biopharmaceuticals to the U.S. grew to nearly match the import value. Last year, the U.S. imported 694.7 million dollars worth of biopharmaceuticals, a 7% increase from the previous year. The share of North America in the total exports of domestically produced biopharmaceuticals also expanded significantly over the past year. By continent, the North American region's share increased by 5 percentage points, from 14.7% in 2023 to 19.4% last year. The US ranked second in biopharmaceutical exports, following Hungary. Hungary's biopharmaceutical exports totaled USD 1.23346 billion, followed by Turkey (USD 432.06 million) and Brazil (USD 144.04 million). The analysis is that exports of biopharmaceuticals to the United States have been increasing in line with the growth of the domestic biosimilar industry. Biosimilars developed by domestic companies such as Celltrion and Samsung Bioepis are rapidly expanding their market share in the United States. Celltrion received four biosimilar approvals in the US this year alone, while Samsung Bioepis launched “Pyzchiva,” a biosimilar version of the autoimmune disease treatment “Stelara,” and ‘Epysqli,” a biosimilar version of the rare disease treatment “Soliris” in the US market this year. (Source:KoBIA) Top 10 biopharmaceutical export/import nations With exports of biopharmaceuticals to the U.S. on the rise, domestic companies are closely monitoring the Trump administration's tariff imposition. As the U.S. is a major export destination for Korean biopharmaceuticals, there are concerns that the imposition of tariffs will inevitably deal a blow to the domestic biopharmaceutical export industry. U.S. President Donald Trump recently announced plans to raise tariffs on certain pharmaceutical products by up to 250%. President Trump stated, “We will impose tariffs on certain pharmaceutical products soon, raise the tariff rate to 150% after one year, and then to 250% thereafter.” As the U.S. is set to announce the results of its Section 232 investigation under the Trade Expansion Act of 1962, the industry believes that the imposition of tariffs on pharmaceutical products is highly likely. Section 232 of the Trade Expansion Act allows the Department of Commerce to investigate the impact of imported goods on national security and enables the president to take appropriate measures. The US government launched an investigation into this matter in April. In line with this policy direction, domestic and foreign pharmaceutical and biotechnology companies have been accelerating their production investments in the US. AstraZeneca and Roche have each announced investments of USD 50 billion, Johnson & Johnson USD 55 billion, Eli Lilly USD 27 billion, Novartis USD 23 billion, and Sanofi at least USD 20 billion to expand their manufacturing capabilities in the US. Domestic companies such as Celltrion are also rushing to enter the U.S. market and secure production bases. Celltrion is reportedly in talks to acquire Eli Lilly's monoclonal antibody production plant in Branchburg, New Jersey. Earlier, Jung Jin Seo, chairman of Celltrion Group, stated that the company is pursuing the acquisition of a U.S. active pharmaceutical ingredient (API) plant to reduce uncertainties related to U.S. tariff risks.
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- 'Vanrafia' for rare kidney disease receives ODD in Korea
- by Eo, Yun-Ho Aug 12, 2025 06:16am
- A new drug for rare kidney disease, 'Vanrafia,' has been granted orphan drug designation in Korea. The Ministry of Food and Drug Safety (MFDS) recently announced this through notificiation board. The indication for the designation is to 'treat adult patients with primary immunoglobulin A nephropathy (IgAN) with a urine protein-to-creatinine ratio (UPCR) over 1.5g/g.' Vanrafia (atrasentan) received accelerated approval from the FDA in April. This drug is a once-daily oral non-steroidal therapeutic agent that can be used in combination with supportive therapy, including a renin-angiotensin system inhibitor. It can also be used in combination with an SGLT-2 inhibitor. The efficacy of Vanrafia was proven through an interim analysis of the Phase 3 ALIGN study. The study has not yet proven whether Vanrafia can slow the decline of kidney function in patients with IgAN. However, in the ALIGN study, patients who received Vanrafia in combination with RAS inhibitor had a clinically and statistically significant 36.1% reduction in proteinuria compared to the placebo group. These results were observed as early as week 6 and were sustained for 36 weeks. The effect of Vanrafia on UPCR was consistent across all subgroups in the primary study cohort, including those with different baseline disease characteristics such as age, gender, race, eGFR, and proteinuria. Meanwhile, IgAN is a progressive, rare autoimmune kidney disease where the immune system attacks the kidneys, often causing glomerular inflammation and proteinuria. Up to 50% of IgAN patients with persistent proteinuria progress to kidney failure within 10-20 years of diagnosis, requiring maintenance dialysis and kidney transplantation. The response to treatment can be varied.
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- US Biosecurity Act passing is ramping up
- by Kim, Jin-Gu Aug 12, 2025 06:14am
- The U.S. Congress is re-pursuing the Biosecurity Act, which failed to pass last year. The bill explains a comprehensive set of sanctions against companies designated as 'biotechnology companies of concern.' Analysis suggests that the bill's chances of passing have increased, as it addresses the procedural issues that were a stumbling block last year. The pharmaceutical industry anticipates that if this bill, which targets Chinese biotech companies, passes, Korean biotech companies could benefit from it. According to the Korea Biotechnology Industry Organization on August 11, Senators Bill Hagerty (Republican) and Gary Peters (Democrat) recently submitted an amendment to the National Defense Authorization Act to the Senate. This amendment incorporates the contents of the Biosecurity Act that were not passed last year. The core of the bill is similar to last year's version. The U.S. administration would be able to designate 'biotechnology companies of concern.' These designated companies would be restricted from federal procurement, contracts, loans, and grants within the U.S. Specifically, U.S. government agencies would be prohibited from procuring or acquiring biotech equipment and services from designated companies. They could not enter into, extend, or renew contracts for equipment and services produced or provided by these companies. Loans and grants could not be used to procure, acquire, or use equipment and services from these companies. However, the restrictions on equipment and services produced or provided under existing contracts would be deferred for five years. The Biosecurity Act was previously pursued by the U.S. Congress last year but failed. This was due to issues raised during the legislative process concerning the lack of transparency in the designation procedure for 'biotechnology companies of concern.' At the time, five Chinese biotech companies, including WuXi Biologics, were identified as targets for regulation, leading to criticism that the process of how they were specifically designated was unclear. The absence of a procedure for removing a company from the list of concern was also a point of criticism. The newly proposed bill aims to address these concerns. The bill explains that if a company is designated as a 'biotechnology company of concern,' the U.S. government must: ▲Notify the company of its designation ▲Provide the reasons for the designation to the extent consistent with national security and law enforcement interests ▲Allow the company to submit arguments opposing the designation within 90 days of receiving the notice ▲Explain the relevant rules and procedures ▲Inform the company about the process for rescinding the designation. These measures are being pursued not as a standalone bill but as an amendment to the NDAA. It would create a new 'SEC. 881' at the end of Title VIII, Subtitle E of the NDAA, specifically 'prohibiting contracts with certain biotech providers.' If the bill passes, the U.S. Office of Management and Budget (OMB) must publish a list of 'biotechnology companies of concern' within one year of the NDAA's enactment. The designated companies would be Chinese military companies operating in the U.S. that the Department of Defense publishes annually in the Federal Register. Also, the targets include: ▲Institutes that are subject to the administrative governance structure, direction, or control of, or are operated on behalf of, a government of a foreign adversary ▲Institutes involved in some capacity in the manufacturing, distribution, provision, or procurement of biotech equipment and services; and ▲Institutes that pose a risk to national security. The subsidiaries, parent companies, and affiliates of these entities would also be included. Industry analysis suggests that the bill's chances of passing are higher than last year's, as the procedure for designating and delisting 'biotechnology companies of concern' has been improved. It is also anticipated that the affected companies will mount a more intense backlash and lobbying effort. In the U.S., it is anticipated that the Senate could begin deliberating the bill as early as this September. If the bill passes, Korean biotech companies are expected to benefit. It is anticipated to be a significant opportunity for the overseas expansion of Korean Contract Development and Manufacturing Organization (CDMO) companies. However, concerns are also being raised that Korean companies could be negatively impacted, as many domestic firms currently collaborate with the Chinese companies in question. There is apprehension that companies working with firms like WuXi Biologics and WuXi AppTec could face disruptions to their business operations. Additionally, concerns have arisen that a strategy must be developed to differentiate Korea from other countries that also seek to fill the gap left by China. While China's absence presents a clear opportunity for Korea, the same holds for other countries, such as Japan and India. Consequently, they must consider ways to win the competition against these rivals.
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- Gilead’s Livdelzi receives orphan drug designation in KOR
- by Eo, Yun-Ho Aug 11, 2025 06:05am
- The new primary biliary cholangitis drug ‘Livdelzi’ has received the orphan drug designation in Korea. The Ministry of Food and Drug Safety announced the news in a public notice on the 4th. Specifically, the designated indication is “the treatment of primary biliary cholangitis (PBC) in adults who have an inadequate response or intolerance to ursodeoxycholic acid.” Livdelzi (seladelpar) was also designated as a candidate for the Global Innovative Products on Fast Track (GIFT) program in June. PBC is a rare, intractable autoimmune disease characterized by chronic inflammation and destruction of the bile ducts in the liver, leading to bile stasis and liver damage, which can then potentially progress to cirrhosis and liver failure. While ursodeoxycholic acid (UDCA) is currently used as the first-line treatment, there has been an ongoing need for new treatment strategies for patients who have an inadequate response to UDCA or experience intolerance. Seladelpar is an oral selective peroxisome proliferator-activated receptor (PPAR) delta agonist. This drug demonstrated efficacy in a Phase III RESPONSE study. The RESPONSE study was a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of seladelpar compared to placebo in adult PBC patients with inadequate response to UDCA or intolerance to UDCA. Study results showed that 62% of patients in the seladelpar treatment group achieved the primary endpoint (composite biochemical response, defined as improvement in alkaline phosphatase (ALP) levels and total bilirubin levels) at 12 months, demonstrating statistically significant superiority over the 20% in the placebo group. Notably, 25% of patients in the seladelpar treatment group achieved normalization of alkaline phosphatase (ALP) values, demonstrating significance. The efficacy of seladelpar was also confirmed in the improvement of pruritus, a key secondary endpoint. Compared to baseline, at 6 months, the seladelpar treatment group showed an average reduction of 3.2 points in pruritus scores among patients with moderate-to-severe pruritus, demonstrating a statistically significant improvement compared to the placebo group's reduction of 1.7 points. Meanwhile, Livdelzi was granted accelerated approval by the U.S. FDA in August last year and was approved in Europe in February this year.
