Telitacicept

泰它西普交出了IgAN领域证据等级最高的一份答卷。 10月22日，2026年美国肾脏病学会年会（ASN Kidney Week 2026）在丹佛开幕，荣昌生物泰它西普的III期TELIGAN研究104周最终结果在开幕式“高影响力临床试验”环节（类似于肿瘤大会LBA）由北京大学第一医院吕继成教授正式报告。TELIGAN是目前为止规模最大的中国人群IgA肾病III期临床研究，入组318例高进展风险患者，横跨全国72家中心。 TELIGAN研究核心数据显示：104周总年化eGFR斜率泰它西普组-0.6 mL/min/1.73m²/年，组间差异5.1；B阶段减频给药下UPCR较安慰剂仍降低60.7%；终末期肾病（ESKD）事件0例 vs 安慰剂组5例；Gd-IgA1在III期层面首获确证性降低。 eGFR年化斜率是衡量肾功能长期趋势的金标准硬终点，而这一终点的2年读出，为泰它西普从“替代终点获批”迈向“硬终点定性”提供了高级别循证证据。 IgAN赛道内有一句行业“黑话”：蛋白尿降幅决定入场券，2年斜率决定身位。而现在，泰它西普把身位亮出来了。 IgAN这个自免现金流大适应症，开始源源不断地为荣昌生物的商业化引擎注入燃油。 01 硬终点交卷：-0.6意味着什么？ 要读懂泰它西普这次的数据有多强，需要先把IgAN领域的指标层级理清楚。 肾脏病学界评价IgAN药物的证据链，从上到下分三档：最高是eGFR年化斜率和复合肾脏终点/ESKD事件，这是金标准硬终点，代表真实的肾功能保护和肾衰竭风险降低；中间层是eGFR下降≥30%/≥40%的风险比例，属于替代终点中证据等级较高的一档；最底层是UPCR蛋白尿降幅，它是全球监管机构接受的加速审批终点，但毕竟只是一个替代指标。 此前泰它西普获批、登上NEJM，凭的是39周A阶段UPCR降幅55%的替代终点数据。而104周最终结果公布，泰它西普正式拿到了金标准硬终点的成绩单。 首要分析最核心的eGFR年化斜率指标，泰它西普组104周总年化eGFR斜率为-0.6 mL/min/1.73m²/年，安慰剂组为-5.7，组间差异5.1。 -0.6是什么概念？ 两个参照系可以帮助理解：第一，健康人的eGFR每年自然衰减约1 mL/min/1.73m²，泰它西普把IgAN患者的肾功能下降速度控制到了比健康人还慢，基本等于“2年不恶化”；第二，未经治疗的IgAN患者eGFR年降幅通常在3-5 mL/min/1.73m²，安慰剂组的-5.7完全吻合这个自然病程，而治疗组直接拉平到了接近零，这个水平落在KDIGO 2025指南设定的“eGFR年降<1”长期肾保护目标区间内。 在各个竞品三期入组人群、对照组发挥差异巨大背景下，组间差异的数值非常值得重视。 5.1的eGFR斜率差在跨试验间接比较中，处于已获批IgAN药物中绝对获益最大的位置：阿塞西普（atacicept，TRUTAKNA/ORIGIN 3）2年斜率差+5.0、斯贝利单抗（sibeprenlimab，VOYXACT/VISIONARY）+4.5、伊普可泮（iptacopan，（Fabhalta/APPLAUSE-IgAN）约+3.0。泰它西普的5.1虽然与阿塞西普和斯贝利单抗处于同一量级（跨试验不可直接排序，人群和口径均有差异），证明了它在B细胞通路药物处于第一梯队。 ESKD事件的对比分量同样很重：泰它西普组104周是零ESKD事件，安慰剂组是5例。 在肾脏领域，“治疗组零事件 vs 对照组数例”是最硬的临床证据之一，意味着在整整2年的随访中，没有一个接受泰它西普治疗的患者走到需要透析或肾移植的终点。eGFR下降≥30%的风险降低和≥40%的风险降低数据同样支持这一判断，进一步加固了泰它西普长期肾脏保护的证据链。 随着随访时间拉长、药物减频治疗，接受泰它西普治疗的患者蛋白尿指标同样在持续加深。 39周A阶段UPCR较安慰剂下降55%，到104周B阶段减频给药（从每周一次降至每两周一次）背景下，UPCR降幅不减反增，达到60.7%。这说明减频并没有牺牲疗效，蛋白尿抑制仍在持续加深。 值得单独拿出来说的，还有Gd-IgA1数据。 Gd-IgA1（半乳糖缺陷型IgA1）是IgAN“四重打击”学说中的第一重打击，是整个致病链的起点。泰它西普作为BLyS/APRIL双靶点抑制剂，从机制上就应该能降低Gd-IgA1，但此前只有II期小样本数据支撑这一推论，NEJM发表的A阶段摘要中也未披露Gd-IgA1。104周数据首次在III期层面确证了泰它西普对Gd-IgA1的显著抑制，把“四重打击第一重”的机制证据从假设推演升级为随机对照确证。 分析了那么多疗效数据，泰它西普在IgAN领域处于一个什么身位？ 在104周数据公布之后，泰它西普在IgAN领域的定位已经从“中国获批的替代终点药物”升级为“拥有2年硬终点数据的B细胞通路一线选手”。它的eGFR斜率保护水平与全球最强的B细胞通路竞品处于同一档位，ESKD零事件提供了额外的安全感，蛋白尿与Gd-IgA1的持续抑制构成了从替代终点到机制终点的完整证据链。 它可能无法说自己是最强的IgAN治疗药物，但绝对是证据链最充足、疗效最顶的现有获批药物之一。 02 安全依从双优势：贴合IgAN患者的真实需求 疗效数据够硬只是第一步，IgAN患者的真实需求还有另外几层。 药物起效速度首先就是最大考验，IgAN患者最直接的痛苦来自持续性蛋白尿和血尿带来的焦虑与生活质量下降，很多患者在确诊后最焦虑的问题就是“药什么时候起效”。 而泰它西普的一个突出优势是起效快：TELIGAN研究中，泰它西普组在第4周即与安慰剂达到统计学分离，蛋白尿快速下降，分离度此后持续扩大至39周乃至104周。对比部分竞品需要2-3个月才能看到明确获益，泰它西普“第一个月就有感”的特点，对患者依从性和治疗信心都有正向驱动。 这个特点往深了看，快速起效的背后是BLyS/APRIL双靶点对致病性B细胞和浆细胞的快速抑制，这从39周的免疫学数据中可以得到印证：IgA下降60.6%、IgG下降32.0%、IgM下降74.9%、CD19+B细胞下降46.4%，全链条免疫球蛋白和B细胞同步收缩，速度和深度都很可观。 同样，能不能覆盖多数IgAN患者需求也是个大问题。 TELIGAN研究纳入的是优化RASi治疗后仍有UPCR≥0.8 g/g的高进展风险患者，基线平均eGFR 75.5 mL/min/1.73m²，约1/3的患者eGFR<60（CKD 3期），35%联用SGLT2i。 说白了，这不是一群“轻症好治”的患者，而是中重度、活动性强、在现有标准治疗基础上仍在进展的真实世界切面，入组标准覆盖了IgAN最大的治疗需求人群，这意味着泰它西普后续能够满足多数患者治疗需求。 作为自免药物，安全性好是患者长期用药的前提。 泰它西普104周的安全性成绩单在免疫调节类药物中相当罕见。整个研究期间，泰它西普组SAE（严重不良事件）发生率8.2%，安慰剂组18.2%，治疗组SAE率不到安慰剂的一半。免疫抑制类药物中SAE率显著低于安慰剂，这在肾脏甚至整个自免领域都极为少见，提示泰它西普的免疫抑制是选择性的，靶向致病B细胞和浆细胞而非广谱抑制免疫系统。 另外感染风险是免疫调节药物长期使用的核心关切，尤其是IgAN患者往往需要数年甚至终身治疗。104周数据给出了明确答案：泰它西普组与安慰剂组总体感染率均为67.3%，严重感染率分别为1.9%和4.4%，两年治疗未增加感染风险。IgAN是一种20-40岁高发的青壮年疾病，这部分患者对安全性的敏感度远高于晚期肿瘤患者，能在2年维度上保持“不增加感染负担”的安全性表现，也是长期用药的关键前提。 依从性方面，TELIGAN的临床设计本身就蕴含着对患者用药习惯的深度考量。A阶段每周一次皮下注射×39周诱导，B阶段切换为每两周一次×32剂维持。“诱导期密集、维持期减频”是目前自免领域公认的最优给药节奏，既保证了起效阶段的充分暴露，又降低了长期治疗的注射负担。104周数据证实减频后UPCR降幅从55%加深至60.7%，说明Q2W维持剂量完全能够保住甚至扩大疗效，减频不减效。 皮下注射给药本身也有一定优势。相比口服药物需要每天服药的“慢性消耗感”，有患者反馈低频的皮下注射反而有更强的"治疗获得感"，注射部位反应泰它西普组较常见（56.0% vs 18.9%），但绝大多数为轻中度。有人可能担心高频皮下注射的依从性，但泰它西普在SLE适应症上已经用同样的一周一次给药方案教育市场五年，患者接受度成熟。 综合来看，快速起效+长期安全+减频不减效+成熟的给药方式，构成了泰它西普贴合IgAN患者真实需求的四重优势。 03 中国全人群的含金量：从数据到商业化的完整链条 TELIGAN是一项纯中国人群的III期研究，这个标签在不同疾病领域有截然不同的含义。 放在肿瘤领域，中国全人群可能被视为证据等级的折扣项，因为FDA和EMA更看重全球多中心数据的外推性。但放在IgAN领域，中国全人群的含金量恰恰是最高的。 原因很直接：IgAN疾病负荷呈“西低东高”梯度，东亚是全球最高发区，而中国是全球最大的单一国家IgAN患者池。弗若斯特沙利文保守口径约220万患者（2020年），行业实际口径高达500万，年新确诊超过10万例。IgAN占中国活检确诊原发肾小球疾病的39.73%，是当之无愧的第一大病因。 在这样一个患者池高度集中在中国的疾病里，中国全人群III期的证据权重远高于一般认知。TELIGAN恰恰是在这个最大患者池里做出来的最大规模III期，登顶NEJM+ASN开幕式口头报告双重背书，循证等级拉满。多项全球III期中的中国亚组数据也从侧面印证了这一点：VISIONARY研究中，中国亚组蛋白尿降幅比全球值高出10.7个百分点，提示中国人群对B细胞通路药物可能更敏感。 商业化层面，IgAN的推广效率天然优于其他自免疾病。IgAN患者诊断和治疗高度集中在头部三甲医院的肾内科，不像SLE、RA等自免疾病那样分散在风湿免疫科甚至基层，推广覆盖的集中度远高于传统自免。 目前泰它西普目前已有SLE、RA、重症肌无力、干燥综合征、IgAN五个自免适应症上市，作为第五个获批的适应症，IgAN可以复用荣昌生物已经建成的覆盖1200余家核心医院、约900人自免销售团队。边际推广成本极低，新适应症收入的大部分增量可以直接转化为利润。 值得注意的是，荣昌生物在2026年Q2基础业务（剔除BD收入）已实现扭亏，已经充分说明创新药商业化网络已具备盈利能力。IgAN作为第五个适应症叠加2年硬终点数据的背书，新增患者几乎不需要额外的渠道和团队投入，每一分增量收入大概率可以高于前几个适应症的边际利润率落地。也就是说后续IgAN适应症收入放量，有望显著提升产品线整体的毛利率和现金流贡献。 结语：泰它西普在ASN Kidney Week 2026，凭借着2年硬终点数据完成了自我全新升级，从一款替代终点获批的中国FIC新药，摇身一变成为金标准eGFR斜率全球第一梯队的B细胞通路顶级选手。 全球最大的中国患者池叠加现有成熟的商业化网络，接下来，唯有静待商业化快速放量了。 联系我们 I-RNA 2027 展位火热预定中！ 扫码立即咨询 电话：13816031174 （同微信） 赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。 点击此处“阅读全文”咨询更多精彩！

Annualized eGFR slope of -0.6 vs. -5.7 mL/min/1.73 m²/year for placebo, a 5.1 mL/min/1.73 m²/year treatment difference (p<0.001) 89% and 81% reductions in risk of confirmed ≥30% and ≥40% eGFR declines, respectively Proteinuria reductions sustained through 104 weeks following transition to every-other-week dosing; favorable safety profile BOSTON, Oct. 22, 2026 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced final two-year results from the Phase 3 TELIGAN trial evaluating telitacicept in adults with IgA nephropathy (IgAN), conducted in China by its collaborator, RemeGen Co., Ltd (HKEX: 9995, SHA: 688331). TELIGAN met the Stage B primary endpoint, demonstrating a statistically significant difference in annualized estimated glomerular filtration rate (eGFR) slope through 104 weeks compared with placebo. The data were presented today in an oral presentation (TH-OR111) during the Featured High-Impact Clinical Trials plenary session at the American Society of Nephrology (ASN) Kidney Week 2026 in Denver, Colorado. The 104-week findings build on the previously reported 39-week results, published in The New England Journal of Medicine in May 2026, and extend the evidence from proteinuria reduction to longer-term preservation of kidney function and reduced incidence of clinically relevant kidney disease progression events. “At 104 weeks, TELIGAN demonstrated a substantial reduction in proteinuria and important evidence of durable kidney protection,” said Jean-Paul Kress, M.D., Chairman and Chief Executive Officer of Vor Bio. “An annualized eGFR slope approaching zero, lower rates of kidney function deterioration, and sustained proteinuria reductions following the transition to every-other-week dosing together reinforce the clinical potential of telitacicept. These findings add to the growing body of evidence supporting dual BAFF/APRIL inhibition as we continue to advance our global Phase 3 programs in myasthenia gravis and Sjögren’s disease.” TELIGAN is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial that enrolled 318 adults with biopsy-confirmed IgAN receiving stable background supportive therapy. Patients were randomized 1:1 to telitacicept 240 mg or placebo. Treatment was administered subcutaneously once weekly through Week 39 (Stage A), followed by every-other-week dosing from Week 40 through Week 104 (Stage B). The Stage A primary endpoint assessed change in 24-hour urine protein-to-creatinine ratio (24h-UPCR) at Week 39; the Stage B primary endpoint assessed annualized eGFR slope through Week 104. Key Findings from the Final 104-Week Analysis: Kidney function preservation: Annualized eGFR slope through 104 weeks was -0.6 mL/min/1.73 m²/year (95% CI: -1.7 to 0.4) for telitacicept versus -5.7 mL/min/1.73 m²/year (95% CI: -7.0 to -4.5) for placebo, representing a between-group difference of 5.1 mL/min/1.73 m²/year (95% CI: 3.5 to 6.7; p<0.001). Reduced kidney disease progression: Telitacicept was associated with an 89% lower risk of confirmed ≥30% eGFR decline (HR 0.11) and an 81% lower risk of confirmed ≥40% eGFR decline (HR 0.19) relative to placebo. No patient in the telitacicept group experienced a prespecified composite kidney failure endpoint event, compared with five in the placebo group, including two who required dialysis. Durable proteinuria reduction: At Week 104, 24h-UPCR decreased 60.3% from baseline in the telitacicept group compared with a 0.9% increase in the placebo group, representing a reported placebo-adjusted reduction of 60.7%. At Week 104, 44.0% of telitacicept-treated patients achieved 24h-UPCR <0.5 g/g versus 8.2% in the placebo group. Reductions in proteinuria were maintained after the transition to every-other-week dosing. Reduction in pathogenic IgA1: At Week 104, serum galactose-deficient IgA1 (Gd-IgA1) decreased 47.79% from baseline with telitacicept, compared with a 19.06% increase with placebo, consistent with the drug’s dual BAFF/APRIL mechanism. Safety: Treatment-emergent adverse events occurred in 95.0% of telitacicept-treated patients and 89.3% of placebo-treated patients. Serious adverse events occurred in 8.2% versus 18.2%, respectively. Overall infections were reported in 67.3% of each group, and serious infections in 1.9% versus 4.4%. Injection-site reactions were more frequent with telitacicept (56.0% versus 18.9%), with most mild to moderate in severity. In June 2026, telitacicept received conditional approval in China for the reduction of proteinuria in adults with primary IgAN at risk of disease progression. RemeGen is responsible for the development and commercialization of telitacicept in China, while Vor Bio holds exclusive rights to develop and commercialize telitacicept outside Greater China. About IgA Nephropathy IgA nephropathy (IgAN) is one of the most common primary glomerular diseases worldwide and a leading cause of chronic kidney disease. It is characterized by deposition of IgA-containing immune complexes in the kidneys, resulting in inflammation, proteinuria, hematuria, and progressive loss of kidney function. Overproduction of Gd-IgA1 is a central driver of IgAN, and despite available therapies, patients remain at risk of progression to kidney failure. About Telitacicept Telitacicept is a novel recombinant fusion protein designed to treat autoimmune diseases through dual inhibition of BLyS (BAFF) and APRIL - two cytokines essential to B cell and plasma cell survival. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology. Telitacicept is approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), generalized myasthenia gravis (gMG), IgA nephropathy (IgAN), and Sjögren’s disease (SjD). Vor Bio is advancing telitacicept in global Phase 3 trials in gMG and SjD to support potential regulatory approvals in the United States, Europe, and Japan. About Vor Bio Vor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. The Company is focused on rapidly advancing telitacicept, a novel dual-target fusion protein, through Phase 3 clinical development and potential commercialization to address serious autoantibody-driven conditions worldwide. For more information visit . Vor Bio routinely posts information that may be important to investors in the “Investors” section of its website. The Company encourages investors to consult that section of its website regularly. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “design,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “should,” “update,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements regarding the therapeutic and clinical potential of telitacicept, including its potential benefits in IgAN and other autoimmune diseases, its potential to preserve kidney function and slow disease progression, and the durability of its effects; the potential of dual BAFF/APRIL inhibition; the conditional approval of telitacicept in China and any conversion to full approval; Vor Bio’s development and commercialization plans, including potential regulatory approvals in the United States, Europe, and Japan; and other statements that are not historical fact. Vor Bio may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including that results from the TELIGAN trial, which RemeGen conducted solely in China, may not be predictive of results in other populations or in our ongoing or future clinical trials, and that the FDA and other regulators outside China may not accept data generated in China; that results of earlier clinical trials or analyses may not be predictive of future results, and that data presented at medical meetings may change following additional analysis or peer review; the risk of unexpected adverse events or safety findings; that conditional approvals in China may be withdrawn or not converted to full approval; our reliance on RemeGen, including for clinical data and the supply of telitacicept, and our ability to maintain our license with RemeGen; competition from other therapies, including other BAFF and/or APRIL inhibitors; that the data for our product candidates may not be sufficient for obtaining regulatory approval to commercialize products; we may not be able to execute our business plans, including meeting our planned clinical and regulatory milestones and timelines; and possible limitations of financial and other resources. The clinical trial results described in this press release are based on information reported by RemeGen; Vor Bio has not independently verified these data. These and other risks are described in greater detail under the caption “Risk Factors” included in Vor Bio’s most recent annual or quarterly report and in other reports it has filed or may the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Vor Bio expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law. CONTACT: Media & Investor Contacts: Carl Mauch cmauch@vorbio.com