Core Insights - GSK plc announced positive results from two phase III studies for its investigational chronic hepatitis B therapy, bepirovirsen [1][8] - Both studies met their primary endpoints, showing a statistically significant functional cure rate when bepirovirsen was combined with the current standard of care [2][8] - GSK plans to submit regulatory filings for bepirovirsen globally in the first quarter of 2026, aiming to position it as a finite six-month therapeutic option for chronic hepatitis B [5][8] Study Results - Treatment with bepirovirsen plus standard care demonstrated a meaningful functional cure rate in patients with baseline HBsAg of 3000 IU/ml or lower [2][3] - Functional cure is defined as the sustained loss of HBsAg and undetectable hepatitis B virus DNA for at least 24 weeks post-treatment [3] - GSK reported that bepirovirsen was particularly effective in patients with baseline HBsAg of 1000 IU/ml or lower, although specific numerical data was not disclosed [3][4] Market Potential - GSK estimates that chronic hepatitis B affects over 250 million people globally, indicating a significant market opportunity for bepirovirsen [5] - If approved, bepirovirsen could be the first therapy to achieve a meaningful functional cure for chronic hepatitis B [5] Stock Performance - Year to date, GSK shares have increased by 50%, outperforming the industry growth of 21% [7]

Core Viewpoint - The article discusses the planned price increases of prescription drugs by U.S. pharmaceutical companies in 2026, despite ongoing pressure from the Trump administration to lower drug prices. The number of drugs set for price increases has risen compared to the previous year, indicating a persistent issue with high drug costs in the U.S. [5][7] Price Increases - U.S. pharmaceutical companies plan to raise prices on at least 350 prescription drugs in 2026, including vaccines for COVID-19, respiratory syncytial virus (RSV), and shingles, as well as the cancer drug Ibrance [5] - The median price increase for these drugs is approximately 4%, consistent with the increase seen in 2025 [5] - In contrast, around 9 drugs will see price reductions, with the diabetes drug Jardiance and its related medications experiencing a price drop of over 40% [5] Comparison with Other Countries - Patients in the U.S. pay significantly higher prescription drug costs compared to other developed countries, often nearly three times as much [7] - Despite agreements reached by Trump with 14 pharmaceutical companies to lower some drug prices, companies still plan to increase prices starting January 1 [7] Specific Company Actions - Pfizer plans to adjust prices for about 80 drugs, including Ibrance, Nurtec, and Paxlovid, with most increases below 10%. However, the price of the COVID-19 vaccine Comirnaty will rise by 15%, and some hospital drugs will see increases exceeding four times their previous prices [7] - European pharmaceutical company GSK intends to raise prices on approximately 20 drugs and vaccines, with increases ranging from 2% to 8.9% [8] Legislative and Market Context - U.S. pharmaceutical companies have been reducing significant price hikes in recent years due to legislative scrutiny and government policies that penalize drug prices exceeding inflation rates [8] - More price adjustments are expected to be announced in early January, a traditional peak period for pharmaceutical price changes [8]

Group 1 - GSK and Ionis Pharmaceuticals have reported positive results from two key Phase III clinical trials for bepirovirsen, a drug aimed at achieving functional cure for chronic hepatitis B (HBV) [1][2] - The global chronic HBV infection population is approximately 254 million, with around 75 million in China, highlighting a significant unmet medical need for effective treatments [1] - Functional cure does not equate to complete virus eradication but significantly reduces the risks of liver cancer and cirrhosis, aligning with current drug development trends in chronic HBV [1] Group 2 - Bepirovirsen, an antisense oligonucleotide (ASO) therapy, aims to identify and destroy the genetic components of the HBV, potentially allowing patients' immune systems to regain control over the infection [2] - Domestic companies are also advancing innovative drug development for functional cure of HBV, with Guangsheng Tang's GST-HG141 and Dongyangguang Pharmaceutical's GLS4 both in Phase III trials [3] - Other companies like Zhimeng Pharmaceutical and Haobo Pharmaceutical are developing HBV core inhibitors and novel ASO drugs, respectively, indicating a growing pipeline for HBV treatment [4] Group 3 - Experts in the field have noted that while functional cure for HBV may not achieve the same results as the complete eradication seen with hepatitis C, the advancements in research are significant for future drug development [5]

Core Viewpoint - GSK's Bepirovirsen has achieved primary endpoints in two key Phase III clinical trials for chronic hepatitis B treatment, potentially leading to the first antiviral therapy that can achieve functional cure in just six months [3][4]. Group 1: Drug Development and Market Potential - Bepirovirsen is a novel antisense oligonucleotide (ASO) therapy that directly inhibits viral replication [3]. - If approved, Bepirovirsen could generate peak annual sales exceeding £2 billion (approximately $2.7 billion), bringing GSK closer to its goal of over £40 billion in annual revenue by 2031 [3]. - Analysts believe that even a 15% to 20% functional cure rate among hepatitis B patients would significantly alter global treatment outcomes [3]. Group 2: Current Treatment Landscape - Chronic hepatitis B (CHB) affects over 250 million people globally and is a leading cause of liver cancer, with over 1 million deaths attributed to it in 2022 according to WHO estimates [4]. - Current standard treatments, primarily nucleos(t)ide analogs (NAs), can effectively suppress viral replication but do not eliminate the virus, requiring lifelong medication for patients [4]. - Data indicates that standard treatments only allow 1% to 4% of patients to clear the virus over time, and these treatments may lead to complications [4]. Group 3: Implications for Future Treatment - If new therapies like Bepirovirsen are approved, there could be a fundamental shift in hepatitis B treatment outcomes in China and globally [5]. - Other pharmaceutical giants, including Roche and Johnson & Johnson, are also actively developing related therapies, indicating a competitive landscape in hepatitis B treatment innovation [5].

Bepirovirsen是一种新型反义寡核苷酸（ASO）乙肝抗病毒疗法，可直接抑制病毒复制。GSK计划于今 年第一季度正式启动Bepirovirsen的全球监管审批申请。 近日由复旦大学附属华山医院感染科张文宏教授等专家最新编撰的《中国高危人群乙型肝炎病毒再激活 防治指南（2026年版）》中援引数据，我国一般人群乙肝表面抗原（HBsAg）流行率为6.1%，慢性 HBV感染者约8600万例。 所谓"功能性治愈"，是指患者停药后在六个月或更长时间内，乙肝表面抗原（HBsAg）持续阴性且检测 不到乙肝病毒（HBV）DNA。分析师认为，即便是15%至20%的乙肝患者实现功能性治愈，这对于改变 全球乙肝治疗结局也将具有重要意义。 目前尚无其他疗法能够在停药后实现显著的功能性治愈率。投行杰富瑞分析师迈克尔·洛伊滕（Michael Leuchten）表示："GSK公布的消息意味着Bepirovirsen有望成为重磅炸弹级药物。" 如果该药物获批，将意味着全球首个仅需6个月有限疗程治疗，便可直接实现乙肝功能性治愈的抗病毒 疗法诞生。 目前针对慢性乙肝的标准治疗方案主要是核苷（酸）类似物（NA），虽然能有效抑制病毒复制，但难 ...

Bepirovirsen是一种具有三重作用机制的在研ASO疗法，旨在识别并破坏乙肝病毒的遗传成分(即RNA)， 从而可能使患者的免疫系统重新获得控制病毒感染的能力。 慢性乙型肝炎是全球范围内的一项重大健康挑战，影响着超过2.5亿人，并且已成为导致肝癌的主要原 因之一。目前，基于核苷(酸)类似物的标准治疗通常需要长期甚至终身用药，但其功能性治愈率仍然偏 低，通常仅约为1%。 GSK(GSK.US)今日宣布，其与Ionis Pharmaceuticals合作开发的在研反义寡核苷酸(ASO)疗法 bepirovirsen，在用于治疗慢性乙型肝炎(HBV)的两项关键性3期临床试验B-Well 1和B-Well 2中取得积极 结果。两项试验均达到主要终点。Bepirovirsen显示出具有统计学与临床意义的功能性治愈率。GSK计 划于2026年第一季度启动全球监管申报。 分析显示，B-Well试验达到了主要终点，且bepirovirsen显示出具有统计学意义并具有临床意义的功能性 治愈率。与单用标准治疗相比，bepirovirsen联合标准治疗显著提高了功能性治愈率。在所有终点中均达 到统计学显著性，包括基线HBsAg ...

Core Insights - GSK shared data from two pivotal Phase 3 studies, B-Well 1 and B-Well 2, for bepirovirsen, an investigational treatment for chronic hepatitis B, involving over 1,800 patients [1] - The studies met their primary endpoint, showing a statistically significant and clinically meaningful functional cure rate for bepirovirsen compared to standard care alone [3] - If approved, bepirovirsen could become the first finite, six-month therapeutic option for chronic hepatitis B [5] Financial and Partnership Details - Ionis received an upfront payment, license fee, and development milestone payments from GSK, with potential additional payments of $150 million and tiered royalties of 10-12% on net sales of bepirovirsen [2] - The collaboration between Ionis and GSK began in 2019 when GSK licensed bepirovirsen from Ionis [1] Study Results and Future Plans - The B-Well studies demonstrated an acceptable safety and tolerability profile consistent with previous studies, with full results to be presented at a scientific congress and submitted for regulatory approvals in early 2026 [4] - The studies showed significantly higher functional cure rates in patients with baseline surface antigen levels ≤1000 IU/ml [3] Analyst Commentary - Analysts from William Blair noted that Ionis is well-positioned with five Phase 3 readouts expected in 2026, highlighting bepirovirsen as an underappreciated opportunity in the market [6] - The performance of Gilead Science's Vemlidy, projected to exceed $1 billion in revenue for fiscal 2025, suggests a growing market for hepatitis B treatments [6] Market Reaction - Following the announcement, Ionis Pharmaceuticals shares increased by 4.06% to $84.80, while GSK shares rose by 1.20% to $51.16 [8]

英国制药巨头葛兰素史克(GSK.US)当地时间周三表示，其用于治疗慢性乙型肝炎感染的试验性药物在 两项备受市场关注的重大临床研究中达到主要目标，这也将使得这一影响全球超过2.5亿人的疾病的功 能性治愈更近一步。此外，这款备受瞩目的新药或将强劲助力葛兰素史克实现雄心勃勃的营收目标。 葛兰素史克的试验报告显示，两项研究中的患者均被监测其病毒DNA与表面抗原水平的持续显著下降 情况。若降低水平可持续6个月或更久，则表明实现功能性全方位治愈。 葛兰素史克暂时未披露接受bepirovirsen治疗后实现功能性治愈的最终患者比例，但表示完整数据将于即 将举行的科学大会上公布。该公司强调，最新的试验数据也将用于在2026年第一季度在国际范围内提交 正式的各项监管批准申请。 bepirovirsen之所以"备受瞩目"，核心在于它瞄准的是慢性乙肝治疗领域公认的"圣杯"——有限疗程后实 现功能性治愈(functional cure)，而不是仅把病毒压下去。 现行标准治疗以核苷(酸)类似物(NAs)为主，能有效抑制HBV DNA，但往往难以清除cccDNA与整合入 宿主基因组的病毒片段，导致HBsAg(表面抗原)清除率在长期治疗下 ...

Core Insights - GSK announced positive results from two pivotal Phase 3 studies, B-Well 1 and B-Well 2, for bepirovirsen, an investigational antisense oligonucleotide for chronic hepatitis B treatment [1] Company Summary - Ionis Pharmaceuticals partnered with GSK for the development of bepirovirsen, which has shown promising safety and efficacy results in over 1,800 patients across 29 countries [1]

Core Insights - GSK's experimental drug for chronic hepatitis B infection has successfully met the main goals in two significant studies, indicating progress towards a potential functional cure for patients [1] Company Summary - GSK is advancing its research in chronic hepatitis B treatment with promising results from its experimental drug [1]