实现乙肝功能性治愈的目标有了新的希望。 当地时间1月7日，葛兰素史克（GSK）对外宣布，公司与Ionis Pharmaceuticals合作开发的bepirovirsen， 在治疗慢性乙型肝炎（HBV）的两项关键性三期临床试验中取得积极结果。完整研究结果也将提交至 即将召开的学会大会进行展示，GSK也计划于2026年第一季度申报上市。该药也有望成为全球首款获批 的乙肝功能性治愈药物。 公开数据显示，全球约有2.54亿慢性乙肝感染者，而目前中国约有7500万乙肝感染者群体。尽管规范抗 病毒治疗已实现长期稳定的病毒抑制，显著改善患者预后，但患者还有着进一步的临床诉求。在中国， 超80%肝癌是由乙肝感染所致 ，慢乙肝患者仍然暴露在肝硬化、肝癌的长期风险之下，患者的治愈需 求亟待满足。 "功能性治愈"并不等于病毒完全清除，但可显著降低肝癌和肝硬化等风险，这一目标也是当前慢性乙肝 药物研发创新的方向。此前，国家药品监督管理局药品审评中心（CDE）发布的《慢性乙型肝炎病毒感 染治疗药物临床试验技术指导原则》 就提出，对适合条件的患者，通过有限疗程治疗，追求临床治愈 （或功能性治愈）。 反义寡核苷酸（ASO）药物、小干扰R ...

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 ...

此次临床补充申请获批的60微克乙肝疫苗，作用机理是通过诱导高水平乙肝表面抗体的产生，建立持久 免疫记忆，帮助已清除慢性乙肝表面抗原人群维持持续的功能性治愈状态，即"防复阳"。在管线定位 上，后续有望作为慢性乙肝功能性治愈患者停药后维持持续治愈的全球创新策略。 （编辑 张伟） 放眼全球市场，乙肝治疗赛道的价值潜力与临床需求缺口同样显著，世卫组织估计全球约有3亿慢性乙 肝感染者，预计2030年全球乙肝治疗市场规模将达1246亿元；其中中国慢性乙肝感染者7500万，2030年 国内乙肝治疗市场规模将突破700亿元。然而，当前乙肝治疗存在仍未满足的临床需求，缺乏可长期巩 固疗效、降低复阳风险的策略。该疫苗如能顺利扩大适应症人群，将显著提升治疗获益，填补国际市场 空白，有望带来数千万级新增患者需求。 本报讯 （记者刘晓一）日前，深圳康泰生物制品股份有限公司（以下简称"康泰生物"）研发的重组乙 型肝炎疫苗（酿酒酵母）（60μg）新增适用人群项目获得国家药品监督管理局出具的《药物临床试验 批准通知书》，批准本品在慢性乙型肝炎功能性（临床）治愈人群中开展预防HBsAg复阳的临床试验。 作为伴随中国疫苗产业成长的龙头企业，康泰 ...

撰文丨王聪 编辑丨王多鱼 排版丨水成文 据估计，全球范围内约有 3.25 亿 人慢性感染了 乙型肝炎病毒 （HBV） ，尽管已有有效疫苗，HBV 仍导致了每年近 100 万人死亡。HBV 的慢性感染会对肝细 胞造成长期损伤，使感染者面临进展性肝病风险，近一半的 肝细胞癌 是因为 HBV 慢性感染所致。 目前，针对慢性乙型肝炎病毒 （HBV） 感染的治疗方法效果不佳，原因是高循环水平的乙型肝炎表面抗原 （HBsAg） 导致了免疫耗竭。 2025 年 12 月 1 日， 悦康药业 宋更申 团队在 Nature 子刊 Nature Communications 上发表了题为： An RNA interference therapeutic potentially achieves functional cure of chronic hepatitis B virus infection 的研究论文。 该研究表明，靶向 乙型肝炎病毒 S 区的 siRNA 药物 KC13-M2G2 ，有望实现慢性乙型肝炎病毒感染的功能性治愈。 这种名为 KC13-M2G2 的 siRNA 制剂在体外对所有乙型肝炎病毒 （HBV） 基 ...

Core Viewpoint - The company has announced promising results from the ENSURE II Phase study, indicating the potential of BRII-179 in achieving functional cure for hepatitis B virus (HBV) infection, with sustained benefits observed in HBsAg clearance among responders [1][2]. Group 1: Study Results - In the BRII-179 responder group, 58% (11 out of 19) achieved HBsAg clearance at the end of treatment (EOT), compared to only 17% (2 out of 12) in the non-responder group [2]. - After 24 weeks post-treatment, 42% (8 out of 19) of the responders maintained HBsAg clearance, while only 8% (1 out of 12) of non-responders did [2]. - Previous studies indicated that 50% (4 out of 8) of responders maintained HBsAg clearance 24 weeks after EOT, even with baseline HBsAg levels between 1,514-3,086 IU/mL, showcasing BRII-179's potential across different patient populations [2]. Group 2: Ongoing Research - The company is conducting two additional Phase IIb studies: ENRICH, which evaluates BRII-179's role in inducing HBV-specific immune responses, and ENHANCE, which assesses the effects of a combination therapy involving BRII-179, elebsiran, and PEG-IFNα [3]. - ENHANCE consists of two parts: one assessing the simultaneous administration of the three drugs for 48 weeks, and the other exploring a sequential approach with 24 weeks of BRII-179 and elebsiran followed by 24 weeks of combination therapy [3]. - Both studies have completed patient recruitment and are expected to report EOT data in 2026 [3].

Group 1 - Braveheart Bio, a biotech startup, has completed a $185 million Series A financing round, led by top life science investment firms. The financing is linked to its sole pipeline product BHB-1893, which originates from China's Heng Rui Medicine. A licensing agreement was established in September 2025 between Heng Rui Medicine and Braveheart Bio for the HRS-1893 project, a small molecule inhibitor of cardiac myosin [1] - Core Medical has been accepted for IPO on the Sci-Tech Innovation Board, becoming the first innovative medical device company to be accepted under the new listing standards. The company has developed five implantable and six interventional artificial heart products, with one implantable product already commercialized and two interventional products in the registration approval stage [2] - Chongqing Precision Bio has received approval from the National Medical Products Administration for its CAR-T therapy product, Pukiorun, aimed at treating acute B lymphoblastic leukemia in children aged 3 to 21. This is the first CAR-T therapy approved in China for treating refractory or relapsed B-ALL in this age group [3] Group 2 - YKYY013, a dual-strand siRNA drug developed by Yuekang Kexin and Tianlong Pharmaceutical, has been approved for clinical trials to treat chronic hepatitis B virus infection. This drug utilizes RNA interference to silence HBV gene transcription, potentially leading to functional cure for hepatitis B [4] - Huahui Anjian has released key clinical data for its monoclonal antibody HH-003, which shows significant efficacy in treating chronic hepatitis D virus infection. The 48-week clinical trial results indicate superior outcomes in composite endpoint response rates, virological suppression, ALT normalization, and liver stiffness improvement compared to the control group [5][6]

Core Viewpoint - Yuyuan Pharmaceutical announced that its subsidiaries have received approval from the National Medical Products Administration to conduct Phase I clinical trials for YKYY013 injection, aimed at treating chronic hepatitis B virus infection [1] Group 1: Company Developments - Yuyuan Pharmaceutical's subsidiary, Beijing Yuyuan Kechuang Pharmaceutical Technology Co., Ltd., and Hangzhou Tianlong Pharmaceutical Co., Ltd. have obtained the clinical trial approval [1] - YKYY013 injection is a chemically synthesized double-stranded siRNA drug that utilizes N-acetylgalactosamine ligands [1] Group 2: Product Details - YKYY013 works through RNA interference to effectively silence the messenger RNA of the HBV genome, thereby inhibiting the production of hepatitis B pathogen proteins and suppressing HBV replication [1] - The drug aims to create conditions for host immune reconstitution, ultimately achieving functional cure for hepatitis B [1]

Core Viewpoint - Yuyuan Pharmaceutical (688658.SH) has received approval from the National Medical Products Administration for its subsidiary Yuyuan Kechuang and Hangzhou Tianlong to conduct Phase I clinical trials for YKYY013 injection, aimed at treating chronic hepatitis B virus infection [1] Company Summary - YKYY013 injection is a chemically synthesized double-stranded siRNA drug developed by Yuyuan Kechuang and Hangzhou Tianlong, utilizing an N-acetylgalactosamine (GalNAc) ligand [1] - The drug works through RNA interference to effectively silence the HBV genome's messenger RNA (mRNA), thereby inhibiting the production of hepatitis B pathogen proteins and suppressing HBV replication [1] - The ultimate goal of YKYY013 is to create conditions for host immune reconstitution, leading to the functional cure of hepatitis B [1] Industry Summary - The approval for clinical trials indicates a significant advancement in the treatment options available for chronic hepatitis B virus infections, which remains a major public health concern globally [1]

Core Viewpoint - YKYY013 injection, developed by the company and Hangzhou Tianlong Pharmaceutical, has received approval from the NMPA for clinical trials aimed at treating chronic hepatitis B virus infection [1] Group 1: Company Developments - The company's subsidiary, Beijing YK Pharmaceutical Technology Co., Ltd. (referred to as "YK Technology"), has been granted a clinical trial approval notice for YKYY013 injection [1] - The clinical trials will focus on the first phase of testing for YKYY013 injection [1] Group 2: Product Details - YKYY013 injection is a chemically synthesized double-stranded siRNA drug that utilizes an N-acetylgalactosamine (GalNAc) ligand [1] - The drug works through RNA interference to effectively silence the HBV genome's messenger RNA (mRNA), thereby inhibiting the production of hepatitis B viral proteins and replication [1] - The ultimate goal of YKYY013 is to achieve functional cure for hepatitis B by creating conditions for host immune reconstitution [1]