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更新于：2026-07-31

Bepirovirsen

贝普若韦生

更新于：2026-07-31

概要

基本信息

药物类型

ASO

别名

Bepirovirsen Sodium、IONIS HBVRx、IONIS-HBVRx

+ [11]

靶点

HBsAg

作用方式

抑制剂

作用机制

HBsAg抑制剂(HBV表面抗原抑制剂)

治疗领域

感染消化系统疾病

在研适应症

病毒感染慢性乙型肝炎

非在研适应症-

原研机构

Ionis Pharmaceuticals, Inc.

在研机构

GSK Plc

葛兰素史克（中国）投资有限公司GlaxoSmithKline Trading Services Ltd.

+ [3]

非在研机构

GlaxoSmithKline Manufacturing SpA

权益机构

Ionis Pharmaceuticals, Inc.

正大天晴药业集团股份有限公司

中國生物製藥有限公司

+ [1]

最高研发阶段申请上市

首次获批日期-

最高研发阶段(中国)申请上市

特殊审评突破性疗法 (美国)、快速通道 (美国)、优先审评 (加拿大)、突破性疗法 (中国)、优先审评 (美国)、优先审评 (中国)、先驱策略 (日本)

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结构/序列

使用我们的RNA技术数据为新药研发加速。

或

查看完整样例数据

Sequence Code 31829872

来源: *****

关联

项与贝普若韦生相关的临床试验

NCT07696520

/ Not yet recruiting临床2期IIT

Bepirovirsen Liver Biopsy Study

Bepirovirsen Liver Biopsy study is a single centre open label phase II study to examine the antiviral and immunological effects of bepirovirsen in CHB patients both treated and untreated with HBsAg<1000 IU/ml

开始日期2026-07-01

申办/合作机构

National University Health System Pte, Ltd.

[+2]

NCT07168356

/ Active, not recruiting临床1期

A Phase 1, Open-Label, Single-Dose, Parallel Group, 2-Part Study to Evaluate the Pharmacokinetics of Bepirovirsen in Adult Participants With Severe or Moderate Renal Impairment Compared to Matched Healthy Control Participants

This is a 2-part study where all participants will receive bepirovirsen. The study will measure how much bepirovirsen from a single dose gets into the blood, and how long it stays in the blood. The purpose of the study is to understand if blood levels of bepirovirsen are different in adults with kidney disease compared to healthy adults who do not have kidney disease.

开始日期2025-09-26

申办/合作机构

GSK Plc

NCT06537414

/ Active, not recruiting临床2期

A Phase 2b, Multi-centre, Randomized, Partially Placebo-controlled, Double-blind Study to Investigate the Safety and Efficacy of Sequential Therapy With Daplusiran/Tomligisiran Followed by Bepirovirsen in Participants With Chronic Hepatitis B Virus on Background Nucleos(t)Ide Analogue Therapy (B-United)

The study is intended to evaluate the efficacy and safety of 2 different doses of DAP/TOM followed by bepirovirsen in participants living with CHB on standard of care nucleos(t)ide analogue (NA) therapy. The study also aims to identify an optimal dose of DAP/TOM for sequenced therapy with bepirovirsen for further clinical development and to assess the contribution of DAP/TOM to the sequential regimen. The study will also include an optional long-term follow-up (LTFU) extension stage for eligible participants.

开始日期2024-11-11

申办/合作机构

GSK Plc

100 项与贝普若韦生相关的临床结果

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100 项与贝普若韦生相关的转化医学

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100 项与贝普若韦生相关的专利（医药）

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项与贝普若韦生相关的文献（医药）

2026-06-25·NEW ENGLAND JOURNAL OF MEDICINE

Phase 3 Results of Bepirovirsen Treatment for Chronic Hepatitis B Virus Infection

Article

作者: Heo, Jeong ; Liang, Xieer ; Franca, Alex ; Peng, Cheng-Yuan ; Asselah, Tarik ; Chen, Chien-Hung ; Idriz, Nevin ; Sevastianos, Vasileios ; Mehta, Rajiv ; Lin, Jianmei ; Lukić, Tamara ; Holmes, Jacinta ; Yim, Hyung Joon ; Hlebowicz, Maria ; Cernat, Roxana ; Xie, Qing ; Jeng, Wen-Juei ; Chuang, Wan-Long ; Yuen, Man-Fung ; Hou, Jinlin ; Qiu, Yunqing ; Cremer, Jennifer ; Quinn, Geoff ; Stocker, Hartmut ; Lim, Seng-Gee ; Ratziu, Vlad ; Terrault, Norah ; Agarwal, Kosh ; Tanaka, Yasuhito ; Lim, Tien Huey ; Riachi, Ghassan ; Nguyen, Huy ; Leerapun, Apinya ; Fujiyama, Shigetoshi ; Gomes da Silva, Monica M. ; Buti, Maria ; Xie, Yao ; Elston, Robert ; Gane, Edward ; Tao, Yu ; Lampertico, Pietro ; Suzuki, Yuichiro ; Plein, Helene ; Theodore, Dickens ; Gadano, Adrian ; Paff, Melanie ; Coffin, Carla S. ; Andreone, Pietro

BACKGROUND:

Treatment with bepirovirsen, an antisense oligonucleotide targeting hepatitis B virus (HBV) transcripts, has the potential to result in a functional cure, defined by at least 24 weeks of a sustained HBV DNA level below the lower limit of quantification (LLOQ) and hepatitis B surface antigen (HBsAg) loss after fixed-duration therapy.

METHODS:

In two replicate, double-blind trials (B-Well 1 and B-Well 2), we randomly assigned adults with noncirrhotic chronic HBV infection in a 2:1 ratio to receive subcutaneous bepirovirsen (at a weekly dose of 300 mg) or placebo for 24 weeks. All the patients were receiving stable nucleoside or nucleotide analogue (NA) therapy and had an HBsAg level of more than 100 to 3000 IU per milliliter. Eligible patients discontinued NA therapy at 48 weeks. The primary outcome was a functional cure at week 72.

RESULTS:

The percentage of patients with a functional cure at week 72 was significantly higher with bepirovirsen than with placebo both in the B-Well 1 trial (in 127 of 650 patients [20%] vs. none of 328 patients) and in the B-Well 2 trial (in 106 of 570 patients [19%] vs. none of 286 patients). In a pooled analysis at 72 weeks, adverse events were reported in 91% of the patients in the bepirovirsen groups and in 73% of those in the placebo groups; serious adverse events were reported in 7% and 4% of the patients, respectively. During the treatment period, adverse events of grade 3 or higher were reported in 16% of the patients who received bepirovirsen and in 3% of those who received placebo; increases in the alanine aminotransferase level were the most common grade 3 adverse events with bepirovirsen (in 6% of the patients).

CONCLUSIONS:

In two phase 3 trials involving patients with chronic HBV infection, a functional cure after the discontinuation of NA therapy was reported in significantly more patients treated with bepirovirsen than in those who received placebo. (Funded by GSK; ClinicalTrials.gov numbers, NCT05630807 and NCT05630820.).

2026-06-01·JHEP Reports

Bepirovirsen induces innate immune activation in the liver potentially through TLR8 signaling

Article

作者: DeHart, Anne ; Tarrant, Jimmy ; Hoang, Bao ; Terry, Rebecca L ; Austin, Daren ; Das, Amitabh ; Galwey, Nicholas ; Jordan, William ; Jones, Kristen ; Ray, Avijit ; Ermler, Megan E ; Delahaye, Jared L ; Theodore, Dickens ; Singh, Jennifer M ; Sherina, Valeriia ; Paff, Melanie ; You, Shihyun ; Nivarthi, Usha

BACKGROUND & AIMS:

Bepirovirsen is an unconjugated antisense oligonucleotide in Phase 3 trials for chronic hepatitis B virus (HBV) infection. Post hoc analyses from a Phase 2a study (chronic HBV participants) indicated immediate cytokine production upon dosing of bepirovirsen, leading to the hypothesis that bepirovirsen may have innate immune stimulatory activity via pattern recognition receptors (PRRs) in hepatic non-parenchymal cells, alongside its known direct antiviral mechanism in hepatocytes.

METHODS:

Cytokine production was evaluated in Phase 2a serum and plasma samples using Myriad RBM, Olink, or MSD panels. Preclinical studies used PBMCs from healthy donors (MSD, flow cytometry) and PRR-overexpressing HEK or THP-1 cells to assess innate immune activation by bepirovirsen. Cytokine protein levels were measured with Luminex or MSD in wild-type (WT) and hTLR8 transgenic mice, while gene expression (RT-qPCR, RNAscope) was analyzed in vivo exclusively in hTLR8 transgenic mice from Shanghai Model Organisms Center (SMOC).

RESULTS:

Many pro-inflammatory cytokines for immune cell recruitment and activation were upregulated in bepirovirsen-treated participants. Similar findings were seen preclinically in PBMCs from healthy donors following bepirovirsen treatment in vitro. Analysis of innate immune activation in PRR-overexpressing cells revealed weak, yet positive (p = 0.00085), induction only when human Toll-like receptor 8 (TLR8) was present. In hTLR8 transgenic mice, but not wild-type mice, bepirovirsen treatment induced pro-inflammatory cytokines, similar to the TLR8 agonist selgantolimod. Kupffer cells and macrophages were identified as the primary responders to bepirovirsen in hTLR8 mouse livers.

CONCLUSIONS:

Clinical and preclinical data show that bepirovirsen elicits an innate immune response, evidenced by induction of inflammatory cytokines. This effect is mediated at least in part by TLR8 agonism, complementing its established antiviral mechanism.

IMPACT AND IMPLICATIONS:

The aim of this study was to characterize additional mechanisms of action for bepirovirsen, including immune activation through PRRs, based on the hypothesis that bepirovirsen may elicit an innate immune response in addition to its antiviral mechanism. Using Phase 2a study samples we show that bepirovirsen induces IFN-γ, TNF, and other cytokines, while in vitro we demonstrate that that bepirovirsen harbors innate immune stimulatory activity, potentially through human TLR8. Furthermore, we show that the innate immune activation induced by bepirovirsen is distinct from that of other ASOs. This study demonstrates that bepirovirsen can induce an innate immune response, likely through TLR8 agonism, in addition to its known antiviral mechanism; however, the clinical impact of this immunomodulatory effect remains unclear and requires further investigation.

2026-05-01·JOURNAL OF HEPATOLOGY

Single nucleotide polymorphisms in the bepirovirsen binding site have limited impact on treatment response in chronic hepatitis B

Article

作者: Angelini, Elise ; You, Shihyun ; Yates, Phillip ; Galwey, Nicholas ; Maynard, Lauren ; Walker, Jill ; Lau, Chi ; Savarese, Michael ; Theodore, Dickens ; Elston, Rob ; Cremer, Jennifer ; Koenig, Alexander ; Speer, Scott D ; Paff, Melanie ; Livingston, Christine M ; Bouquet, Jerome

BACKGROUND & AIMS:

Single nucleotide polymorphisms (SNPs) in the HBV genome may impact the efficacy of novel drugs for chronic HBV infection. This analysis of the B-Clear study (NCT04449029) evaluated the frequency of baseline and treatment-emergent SNPs in the bepirovirsen binding site and their association with virological response.

METHODS:

HBV sequencing was attempted for all baseline samples collected from B-Clear participants and for selected post-baseline samples from participants meeting predefined resistance-monitoring criteria. Participants were categorized according to nucleos(t)ide analogue (NA) treatment status and hepatitis B surface antigen (HBsAg) response. SNPs were identified using next-generation sequencing and reported if the allelic frequency was ≥5%. The effects of binding site SNPs on viral fitness and susceptibility to bepirovirsen were assessed in vitro.

RESULTS:

Baseline sequences were obtained for 40% (90/226) and 96% (219/229) of On-NA and Not-on-NA participants, respectively. Baseline SNPs were identified in 7% (22/309) of participants. These participants showed numerically smaller HBsAg reductions than those without SNPs, but 18% (4/22) achieved transient HBsAg loss. Post-baseline sequences were obtained for 22% (49/226) and 62% (143/229) of On-NA and Not-on-NA participants, respectively. Of 16 post-baseline SNPs, eight were treatment-emergent. SNPs were detected at 12 of the 20 binding site positions; however, only two SNPs had an allelic frequency >50% (C1589A [max 99%] and C1600T [max 99%]). Six SNPs showed sufficient viral fitness to be evaluated for susceptibility to bepirovirsen in vitro. C1589A demonstrated the largest reduction in susceptibility (4.1-fold) to bepirovirsen.

CONCLUSIONS:

Most participants achieved >1 log reductions in HBsAg, including transient HBsAg loss in some. Although participants with baseline SNPs showed numerically smaller HBsAg reductions, further investigation is required to better understand potential mechanisms of resistance to bepirovirsen.

IMPACT AND IMPLICATIONS:

HBV sequence polymorphisms can contribute to antiviral resistance in the treatment of chronic HBV infection. Therefore, it is important for healthcare professionals to understand the prevalence and emergence of single nucleotide polymorphisms (SNPs) within the bepirovirsen binding site and their potential impact on virological response. Findings from this phase IIb clinical study demonstrate that the vast majority (92%) of non-responders, partial responders, or relapsers did not harbor bepirovirsen binding site SNPs. Moreover, participants with binding site SNPs (7% of participants) still achieved reductions in hepatitis B surface antigen. These results suggest that routine testing for specific HBV variants prior to bepirovirsen administration is not currently warranted, and that resistance due to altered sequence complementarity is likely minimal and multifactorial. Ongoing phase III studies of bepirovirsen will provide additional context to further evaluate the need for variant testing and to better elucidate potential resistance mechanisms.

1,303

项与贝普若韦生相关的新闻（医药）

2026-07-30

·Vaccine之家

GSK疫苗半年进账超59亿美元！Shingrix狂卖25.6亿，Arexvy暴涨75%强势反弹

7月28日，葛兰素史克（GSK）公布了2026年第二季度及上半年业绩。在总营收与核心利润双双超预期的表象之下，这份财报呈现出鲜明的“双面性”：一方面，特药与疫苗板块以双位数增长拉动整体业绩；另一方面，两项管线资产的减值计提几乎吞噬了GAAP利润，而高达106亿美元的收购与19亿英镑的降本计划，则勾勒出GSK面向2029年乃至2031年的战略版图。　　这份“一半火焰、一半海水”的财报，恰是GSK新任CEO卢克·米尔斯（Luke Miels）上任半年以来战略逻辑的集中映射。从财报整体数据来看，GSK上半年总营收160.38亿英镑（214.91亿美元），同比增长5%，核心营业利润增长7%。　　但光鲜的核心数据之下，真正的叙事也隐藏在加减之间。作为新任CEO，卢克·米尔斯将肿瘤定位为GSK未来几年的核心增长引擎，与此同时，“Accelerate Growth”三年成本节约计划剑指2029年实现年均19亿英镑节约，旨在将节约下来的资金重新投入研发。　　一边果断止损，一边重金押注未来。有券商医药行业分析师对21世纪经济报道记者表示，GSK正在用一场“减法”为“加法”腾挪空间。而这一切的紧迫性，源自多替拉韦（dolutegravir）2028至2030年间即将到来的专利悬崖。　　能否在专利到期前用新管线填上收入缺口，也将是卢克·米尔斯任上面临的最严峻考验。业绩“双面性” 　　财报数据显示，上半年，GSK特药业务营收达70.08亿英镑（93.92亿美元），同比增长14%。HIV、肿瘤、呼吸免疫三大管线同步实现双位数增长。 HIV板块仍是特药“压舱石”，上半年营收39.02亿英镑（52.28亿美元），同比增长10%。口服复方Dovato销售额14.15亿英镑（18.97亿美元），增长13%；长效注射治疗药物Cabenuva收入8.21亿英镑（11.00亿美元），增长32%；长效预防药物Apretude收入2.60亿英镑（3.48亿美元），大增41%。ViiV Healthcare已将2026年HIV销售增速展望上调至高个位数。　　不过，核心成分多替拉韦（dolutegravir）将于2028至2030年间面临专利悬崖，这为“Accelerate Growth”计划的落地增添了紧迫性。　　肿瘤业务上半年营收10.81亿英镑（14.50亿美元），同比增长22%。PD-L1抑制剂Jemperli销售额4.80亿英镑（6.44亿美元），增长33%，子宫内膜癌与直肠癌新适应症持续拓宽患者群体；BCMA ADC药物Blenrep收入0.59亿英镑（0.79亿美元），同比翻倍，已在49个国家获批。GSK预计Blenrep销售峰值将超过30亿英镑。呼吸免疫领域上半年营收20.25亿英镑（27.14亿美元），同比增长17%。IL-5单抗Nucala销售额10.94亿英镑（14.66亿美元），增长18%，美国慢阻肺适应症上市后需求持续释放；Benlysta收入8.82亿英镑（11.82亿美元），增长12%，自免领域用药人群持续拓宽。作为公司核心业务的疫苗板块，上半年营收44.33亿英镑（59.39亿美元），同比增长6%。其中，带状疱疹疫苗Shingrix销售额19.14亿英镑（25.65亿美元），增长12%，欧洲公共免疫采购支撑需求，海外市场接种率仍有巨大提升空间。RSV疫苗Arexvy收入2.57亿英镑（3.44亿美元），大增75%，受益于澳大利亚两年期供应招标及日本18至59岁高危成人适应症扩展。而普药板块上半年营收45.97亿英镑（61.61亿美元），同比下滑7%。慢阻肺三联疗法Trelegy销售额14.21亿英镑（19.04亿美元），下降6%，美国医保政策变化与仿制药竞争带来持续压力，欧盟监管机构5月拒绝批准Trelegy哮喘适应症扩展。其余呼吸及普药产品普遍受仿制药竞争及价格压力影响，整体延续下降趋势。对于呼吸板块，前不久GSK也在中国市场进行了战略调整。7月18日，GSK宣布与中国生物制药达成合作，开展全再乐（氟替美维吸入粉雾剂，FF/UMEC/VI）和欧乐欣（乌美溴铵维兰特罗吸入粉雾剂，UMEC/VI）在中国内地的商业化运营。　　市场消息称，此次呼吸业务调整波及范围较广，涉及员工数量众多，部分人员或将面临离开医药行业的现实。　　对此，GSK方面表示，公司已对组织架构进行了简化，使其更高效、更敏捷。将把商业组织整合为两个业务单元：处方药业务单元和疫苗业务单元。处方药业务单元会聚焦于呼吸系统疾病、肿瘤、肝病和HIV等重点治疗领域。疫苗业务将继续聚焦成人疫苗。与此同时，也将简化工作流程，提高合作效率并强化关键能力建设。新的组织预计将在未来两个月内逐步完成重组与过渡。管线加减法　　除了呼吸赛道的调整，在管线层面，GSK上半年达成了多项关键里程碑，也做了两项重大减法。　　加法方面，乙肝功能性治愈ASO药物bepirovirsen两项关键III期试验读出阳性数据，FDA已受理上市申请并授予优先审评与突破性疗法认定，PDUFA目标日期为2026年10月26日。肝病新药Efimosfermin在MASH领域获得FDA、中国CDE突破性疗法认定及EMA PRIME认定。　　此外，引进自翰森制药的B7-H3 ADC项目risvutatug rezetecan在中国ARTEMIS-008研究中达到主要终点，成为全球首个在III期临床中取得阳性OS数据的B7-H3靶向ADC。　　减法方面，基于CALM-1/2 III期试验数据，GSK终止了P2X3受体拮抗剂camlipixant在难治性慢性咳嗽领域的开发，确认资产减值13.34亿英镑。同时终止与Alector的合作项目，确认减值3.71亿英镑。这两项减值合计约17亿英镑，直接导致二季度总营业利润下降75%。　　而在7月15日，GSK也宣布完成对Nuvalent的收购，总对价约106亿美元。通过此次收购，GSK获得zidesamtinib（ROS1阳性NSCLC）和neladalkib（ALK阳性NSCLC）两款潜在同类最佳资产。zidesamtinib已获FDA批准（商品名Jideytro），neladalkib的PDUFA日期为2026年11月27日。这是GSK切入肺癌领域的标志性一步。　　与此同时，GSK启动“Accelerate Growth”三年成本节约计划，目标到2029年实现年均19亿英镑节约，节约资金将大部分重新投入研发。　　基于此，GSK将2026年III期临床试验启动数量从此前指引的10项提升至20项以上，公司已在肿瘤、呼吸、肝病、疫苗等领域18项适应症中识别出7项资产的加速机会。GSK还计划在剑桥生物医学园区投资4亿英镑建设全新研发中心。　　展望2026年全年，GSK预计营收增长3%至5%，核心营业利润增长7%至9%。公司维持2031年营收超400亿英镑的长期目标。　　前述分析师直言，今年GSK这份半年报传递的核心信号清晰而明确，GSK正处在一场深刻的战略转型之中。在特药与疫苗等增长引擎上加速奔跑，在失败资产上果断止损，在大手笔并购中布局未来，在成本节约中为研发投入腾挪空间。　　“对于投资者而言，短期GAAP利润的剧烈波动或许令人忧虑，但核心业务的健康增长与管线的全面提速，才是这家百年药企面向下一个五年的真正叙事。”该分析师强调。加入疫苗星球获取疫苗全行业完整报告和书籍 Ps：每天仅需0.2元畅享疫苗书籍，每天1篇精选报告未来一年新增额外500篇聚焦疫苗前沿，营造10000+研发&临床&生产&投资菁英共同关注的目标群聊&合作咨询创新疫苗研发、BD项目交易、投融资等群聊欢迎添加小编加入对应疫苗行业微信群！敬请注明：企业/高校-岗位/研究方向。

2026-07-30

·花果山英才

县区动态｜34.3亿美元！正大天晴连获国际重磅合作

点击上方蓝字给个关注吧今年以来海州区生物医药产业对外开放捷报频传辖区龙头企业正大天晴完成赛诺菲、阿斯利康、葛兰素史克（GSK）三大跨国药企重磅合作两款自主研发创新药成功授权海外两笔交易总额超34.3亿美元充分印证本土原创研发实力获得全球医药行业高度认可近年来，海州区持续深耕生物医药主导产业、全链条搭建创新载体、靠前精准惠企服务的硬核支撑。依托创新载体、AI+生物医药、医药专属算力平台等产业配套，海州区持续培育一流创新土壤，助力本土药企敢闯全球市场、对接全球顶尖资源。自研创新“走出去” 两笔海外授权创下行业新标杆凭借海州完备产业生态培育的自研管线正大天晴两款自主研发创新药成功授权海外两笔交易里程碑总额超34.3亿美元国产创新药全球化布局实现跨越式突破区域生物医药产业创新能级国际影响力同步大幅跃升 2026年3月牵手赛诺菲将自主研发的全球首创（First-in-Class）JAK/ROCK双靶点抑制剂罗伐昔替尼的全球权益独家授权给赛诺菲，交易总额最高达15.3亿美元，创下中国药企在移植领域对外授权交易的最高纪录。 2026年7月落地阿斯利康重磅BD项目与全球呼吸领域龙头阿斯利康签约，将自主研发的慢性阻塞性肺疾病（COPD）创新药TQC3721（PDE3/4抑制剂）海外权益授权给阿斯利康，交易总额最高达19亿美元，创下近三年中国呼吸领域单产品交易额之最。全球资源“引进来” 跨国药企合作扩容惠及国内患者在自研管线扬帆出海的同时正大天晴充分发挥本土商业化渠道优势持续引进全球顶尖创新药品落地国内补齐海州肝病、呼吸赛道产品矩阵为国内患者带来全球前沿治疗方案 5月达成GSK乙肝创新药独家合作与葛兰素史克（GSK）签订独家战略合作，拿下全球首创乙肝治愈新药 Bepirovirsen 中国大陆独家商业化权益。该药物三期临床数据证实可实现慢性乙肝功能性治愈，有望填补国内临床空白。 7月合作再度升级，新增两款重磅呼吸药双方合作版图持续扩容，新增全再乐、欧乐欣两款全球主流呼吸制剂国内独家商业化权限，依托正大天晴成熟的医院准入能力、深度的终端覆盖网络以及行业领先的合规运营体系，两款慢阻肺、哮喘治疗药物将加速国内患者覆盖，提升用药可及性。依托多年深耕，正大天晴在海州打造国内领先的肝病全周期产品矩阵，天晴甘美、润众等成熟产品市场占有率稳居前列；同步布局乙肝治愈、脂肪肝、肝硬化多条创新管线，多款新药进入临床阶段。本次引进全球前沿乙肝新药，将与企业自研管线形成互补协同，进一步巩固海州在全国肝病创新药赛道的龙头地位。全链条创新沃土培育本土药企出海生力军一流的产业生态是药企深耕研发勇闯全球市场的底气所在近年来，海州区锚定生物医药核心主导产业持续发力搭建起从药物发现、临床研发中试生产到成果转化的全链条产业支撑体系如今全区集聚一大批生物医药创新企业上下游配套形成闭环完备的硬件平台产业资源与配套服务为企业自主创新跨国合作筑牢坚实根基下一步海州区将持续聚焦生物医药赛道不断迭代优化产业生态以完善产业配套精准暖心惠企服务为抓手全程护航辖区医药企业双向开放推动企业在国际化发展道路上行稳致远持续打响海州生物医药特色产业名片来源：今日海州

2026-07-30

·新浪财经

医药生物行业周报29W2026：小核酸迎来密集催化期关注相关产业链

核心观点　　2026 年第二季度，全球寡核苷酸赛道已迎来密集兑现期：ASO、siRNA、mRNA、抗体偶联寡核苷酸（AOC）等全技术链路多点爆发。该季度行业核心变革在于治疗范式跃迁、适应症跨界破圈、递送技术迭代等多维度同步落地，本轮集中爆发不仅验证了核酸药物的底层技术价值，更标志着行业竞争从简单的序列优化、靶点跟风，升级为递送技术、平台能力、全局管线布局的全栈突破。　　具体而言，2026 年成为寡核苷酸疗法的监管突破大年：FDA、EMA 密集授予优先审评、突破性疗法认定，一大批核心品种迈入上市冲刺阶段，覆盖慢性感染、代谢慢病、罕见病、自身免疫病等多疾病领域，例如，GSK 与Ionis联合开发的bepirovirsen 作为全球首个进入NDA 阶段的乙肝功能性治愈ASO药物，其FDA PDUFA 日期锁定2026 年10 月26 日；再生元与Alnylam 合作的cemdisiran（C5 靶向siRNA）用于全身型重症肌无力其FDA PDUFA 日期为2026 年11 月；Ionis 用于治疗亚历山大病反义寡核苷酸（ASO）药物zilganersen 等也值得关注。　　同时，近期已有部分关键数据读出：本周，Arrowhead 公布 plozasiran 用于重度高甘油三酯血症（sHTG）全球 Ⅲ 期 SHASTA-3、SHASTA-4 临床试验的主要结果。SHASTA-3、SHASTA-4 研究中，患者甘油三酯相对基线分别实现79%、81%的深度、持久且稳定的中位降幅；2026 年7 月22 日，赛诺菲宣布，其1 类新药普乐司兰钠注射液（商品名：瑞达普?）正式实现在华可及，完成商业化上市；诺华中报显示其收购Avidity 获得的核心AOC 资产之一Delzota，已经向美国FDA 提交了BLA 申请。　　投资建议：小核酸将在2026 年迎来密集催化，行业将迎来全方位突破，建议关注有小核酸布局的创新药及CXO 公司。CXO 产业链建议关注与全球小核酸龙头公司合作企业：联化科技、蓝晓科技、诚达药业、凯莱英、药明康德、诺泰生物等，创新药公司建议关注前沿生物、石药创新、热景生物、悦康药业、必贝特等公司。　　风险提示：新药研发进展的不确定性风险；销售不达预期风险；集采降价超预期的风险等。

100 项与贝普若韦生相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16202

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
病毒感染	申请上市	加拿大	GlaxoSmithKline, Inc.	2026-05-01
慢性乙型肝炎	申请上市	日本	GlaxoSmithKline, Inc.	2026-02-26

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06422767 (CTgov)	临床1期	乙型肝炎	46	Bepirovirsen (Bepirovirsen: Four-Dose SC Injection)	願獵鹹窪獵襯蓋窪獵觸(齋壓獵糧艱壓範淵餘鏇) = 襯淵網範齋醖淵夢壓憲網觸構蓋鬱遞顧窪蓋糧 (餘艱願艱窪範窪範襯壓, 憲選簾鹽網製願築網觸 ~ 鏇繭繭壓鹹衊廠廠膚憲) 更多	-	2026-07-10
				Bepirovirsen (Bepirovirsen: Three-Dose SC Injection)	願獵鹹窪獵襯蓋窪獵觸(齋壓獵糧艱壓範淵餘鏇) = 簾糧鹽鏇獵築齋蓋餘鹽網觸構蓋鬱遞顧窪蓋糧 (餘艱願艱窪範窪範襯壓, 顧築糧簾繭網鏇鏇窪獵 ~ 膚膚顧鑰顧顧繭夢壓積) 更多
NCT05630807 \| NCT05630820 (B-Well 1, Pubmed \| N Engl J Med)	临床3期	慢性乙型肝炎	1,254	Bepirovirsen	顧衊夢鏇鏇衊蓋網構繭(艱鹹築衊鏇選衊選餘鬱) = 齋膚憲餘憲積獵艱壓鏇選鑰鹽憲醖網餘鬱遞觸 (壓鏇製憲艱積艱繭網簾 ) 更多	积极	2026-06-25
				Placebo	鬱襯鹽餘餘艱網廠構鏇(齋顧壓積繭繭廠膚憲製) = 繭壓衊製築鹽範築醖衊製構蓋窪廠願蓋選選糧 (鏇夢簾窪網醖糧襯廠築 ) 更多
NCT05630807 \| NCT05630820 (B-Well 2, Company_Website) 人工标引	临床3期	慢性乙型肝炎	1,800	Bepirovirsen	顧廠醖鹹壓遞願淵壓齋(鹽繭繭選鬱糧憲餘憲齋) = Bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate 齋積繭廠願廠夢簾膚憲 (鹽鏇廠鏇獵鏇鹹淵憲顧 ) 达到	积极	2026-01-07
				Placebo
NCT06058390 (CTgov)	临床1期	乙型肝炎	160	Bepirovirsen (Bepirovirsen 300 mg Vial by HCP)	廠齋鹹蓋鬱願齋夢壓選(積鏇衊製壓壓憲糧鹹觸) = 夢簾鬱獵鹽糧壓積繭糧簾網衊製構構壓餘壓繭 (顧壓網積艱顧鹹衊淵積, 0.049) 更多	-	2025-07-18
				Bepirovirsen (Bepirovirsen 300 mg PFS SSD by HCP)	廠齋鹹蓋鬱願齋夢壓選(積鏇衊製壓壓憲糧鹹觸) = 選廠鏇蓋窪餘鹽構遞鏇簾網衊製構構壓餘壓繭 (顧壓網積艱顧鹹衊淵積, 0.048) 更多
NCT04676724 (B-Together, Pubmed \| J Hepatol)	临床2期	慢性乙型肝炎 HBsAg \| HBV DNA	108	Bepirovirsen 300 mg once weekly for 24 weeks	遞築齋網獵糧願範醖齋(鏇製齋糧齋蓋網窪鏇顧) = The proportions of participants with adverse events and treatment-related adverse events in both treatment windows were similar between treatment arms 壓醖獵糧膚膚簾鏇醖鹹 (衊鏇顧鏇淵顧製膚鬱憲 )	积极	2025-02-01
				Bepirovirsen 300 mg once weekly for 12 weeks
NCT04544956 (B-Fine, CTgov)	临床2期	慢性乙型肝炎	12	Nucleos(t)ide therapy+GSK3228836	膚選願膚醖願鬱廠衊網 = 積醖膚糧鹽膚選壓衊願選網築顧糧獵鑰鹹鬱築 (憲夢觸構鹽鹹齋窪膚夢, 鏇遞鹽憲獵糧構廠繭積 ~ 蓋醖壓積鑰繭窪齋蓋鏇) 更多	-	2024-12-19
NCT04971928 (B-Assured, Pubmed) 人工标引	临床1期	慢性乙型肝炎	24	Bepirovirsen (hepatic impairment participants)	繭壓簾衊製鬱艱醖襯窪(鑰襯膚範製積鹽糧範構): Geometric Mean Ratio = 0.69 更多	积极	2024-09-13
				Bepirovirsen (healthy participants)
NCT04676724 (B-Together \| B-Together study, CTgov)	临床2期	慢性乙型肝炎	108	PegIFN+GSK3228836 (GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks))	築憲壓餘顧餘製遞衊窪 = 觸醖餘憲窪鬱範獵壓製觸製襯簾窪膚簾餘壓衊 (餘獵醖遞選鏇鹹鹽顧築, 網窪簾構網窪簾餘衊顧 ~ 選憲蓋範膚膚顧壓製壓) 更多	-	2024-05-02
				PegIFN+GSK3228836 (GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks))	鹽簾獵範襯顧襯觸顧鏇 = 鬱壓憲醖構築鹹鏇構窪觸觸廠衊選鏇範獵憲鹹 (顧簾鑰膚繭壓網廠製鏇, 齋觸構衊夢鏇獵構網鬱 ~ 獵壓簾鏇衊遞鑰襯膚壓) 更多
NCT04676724 \| EUCTR2020-002979-35-GB (B-TOGETHER, AASLD2023)	临床2期	慢性乙型肝炎 HBsAg \| HBV DNA \| ALT	108	Arm 1 (BPV 300 mg for 24 weeks + PegIFN 180 mcg QW for 24 weeks)	願廠簾積窪範壓蓋鹹憲(壓鬱構鹹鬱願壓膚蓋選) = 積窪餘範選鹽衊齋憲廠繭夢鏇夢製鑰選築壓簾 (膚鑰鹹鏇鏇艱遞簾襯範 )	-	2023-11-10
NCT04676724 (B-Together, AASLD2023)	临床2期	慢性乙型肝炎	-	Arm 1 (BPV 24 wk)	鹽鹽餘鑰獵窪網淵蓋鹹(艱鑰襯襯艱繭壓製齋夢) = 獵夢鹹餘憲鬱壓襯廠襯簾網網壓蓋襯衊齋鹽觸 (廠憲鬱鹽觸艱醖艱蓋衊 )	-	2023-11-10
				Arm 2 (BPV 12 wk)	鹽鹽餘鑰獵窪網淵蓋鹹(艱鑰襯襯艱繭壓製齋夢) = 築鬱選衊範願顧鏇鏇齋簾網網壓蓋襯衊齋鹽觸 (廠憲鬱鹽觸艱醖艱蓋衊 )