A Phase 1b, Open-label, Randomized, Multicenter, Active Comparator Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Combination of APG777 + APG990 in Adults With Moderate-to-Severe Atopic Dermatitis

The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic (PK) parameters of the combination of APG777 + APG990 in adults with moderate-to-severe atopic dermatitis (AD), in comparison to dupilumab. The duration of the study will be approximately 82 weeks for each participant and will consist of a Screening Period (up to 6 weeks), Treatment Period (Baseline-Week 24), and Follow-up Period (Week 28-Week 76).

开始日期2025-06-04

申办/合作机构

Apogee Therapeutics, Inc.

NCT07003425

/ Recruiting临床2期

A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777

This is a multicenter, double-blind, Long-Term Extension (LTE) study to evaluate the long-term safety and efficacy of APG777 in patients with moderate-to-severe AD who have completed treatment in an APG777 Parent Study (NCT06395948).
The LTE study will consist of 3 periods: 1) Screening Visit will coincide with the last visit of the Maintenance Period in the Parent Study 2) Extended Treatment Period 3) Post-treatment Follow-up Period.
This study will be conducted in participants with atopic dermatitis (AD) who completed the Treatment Period in a prior APG777 study and who, in the opinion of the Investigator, would benefit from long-term treatment with APG777.

开始日期2025-05-14

申办/合作机构

Apogee Therapeutics, Inc.

NCT06920901

/ Active, not recruiting临床1期

A Phase 1b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of APG777 in Adults With Mild-to-Moderate Asthma

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and immunogenicity of APG777 in adult participants with mild-to-moderate asthma.
The duration of the study will be approximately 52 weeks (364 days) for each participant and will consist of a Screening Period, Treatment Period, and Follow-up Period.

开始日期2025-03-27

申办/合作机构

Apogee Therapeutics, Inc.

100 项与祖米洛基巴特相关的临床结果

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100 项与祖米洛基巴特相关的转化医学

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100 项与祖米洛基巴特相关的专利（医药）

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项与祖米洛基巴特相关的文献（医药）

2026-03-23·Cureus Journal of Medical Science

Biologic Monotherapies for Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Bayesian Network Meta-Analysis of Established and Investigational Agents

Review

作者: Babul, Najib ; Soliman, Yssra ; Babul, Arya ; Mehta, Devina ; Hussain, Momina

Biologic therapies targeting maladaptive type 2 inflammation have transformed the management of moderate‑to‑severe atopic dermatitis (AD); however, comparative evidence integrating both approved and next‑generation investigational agents remains limited. This Bayesian network meta‑analysis (BNMA) provides the first unified evaluation of all biologic monoclonal antibodies approved as monotherapy for AD (dupilumab, lebrikizumab, tralokinumab) together with emerging immunotherapies, including amlitelimab, rademikibart, rezpegaldesleukin, rocatinlimab, telazorlimab, temtokibart, and zumilokibart, across key efficacy measures. A PRISMA‑2020-compliant systematic review and PROSPERO‑registered protocol (CRD420251162704) identified phase 2-3 randomized, double‑blind, placebo‑controlled trials reporting week‑16 outcomes (week‑24 for rocatinlimab). A Bayesian random‑effects NMA estimated relative risks (RRs) for EASI‑75, EASI‑90, IGA‑AD 0/1, and ≥4‑point improvement in itch Numeric Rating Scale (NRS). Treatment hierarchy was evaluated using both Bayesian (SUCRA) and frequentist (P‑score) approaches. Seventeen randomized controlled trials (RCTs) involving more than 6,000 patients were included in the analysis. Dupilumab demonstrated the most consistent and reliable efficacy across all evaluated endpoints, including improvements in EASI-75, EASI-90, IGA-AD 0/1, and itch NRS. Among investigational therapies, rocatinlimab showed a notable signal for deep clinical responses, although the available evidence remains limited and less precise. Other emerging agents, including rademikibart, temtokibart, and zumilokibart, demonstrated encouraging efficacy profiles, whereas telazorlimab showed comparatively modest clinical benefit. Ranking analyses consistently positioned dupilumab as the most reliable and highest-performing therapy overall, followed by rocatinlimab. Overall, biologic therapies were generally well tolerated in the short term; however, dupilumab remains the only agent supported by extensive long-term safety data extending up to a decade. This analysis relied on indirect comparisons anchored to short‑term placebo‑controlled induction periods, limiting assessment of long‑term safety and durability, particularly for mechanistically distinct agents such as rezpegaldesleukin, a regulatory T cell (Treg) pathway agonist, and rocatinlimab, an OXO pathway inhibitor. Evidence for several emerging therapies was restricted to small phase 2 trials, resulting in wide credible intervals (Crls) and lower certainty in comparative rankings. Trial heterogeneity in baseline severity, ethnic composition, and geographic setting may have introduced residual confounding despite sensitivity and meta‑regression analyses. These factors should be considered when interpreting relative efficacy estimates This NMA demonstrates that dupilumab remains the most reliable and effective biologic monotherapy for moderate‑to‑severe AD, supported by the greatest precision, reproducibility, and long‑term safety. Rocatinlimab shows promising investigational efficacy but requires efficacy and long-term safety validation. Zumilokibart, rademikibart, and temtokibart emerge as additional candidates with encouraging activity, whereas telazorlimab showed limited clinical benefit. Collectively, these findings provide a comprehensive comparative framework to inform biologic selection and therapeutic sequencing.

2025-12-01·INTERNATIONAL JOURNAL OF TOXICOLOGY

Preclinical Safety of APG777, A Novel Extended Half-Life Anti-Interleukin-13 Monoclonal Antibody, in Cynomolgus Monkeys

Article

作者: Rubio, Daniel ; Badger, Drew ; Zhu, Eric ; Funk, Kathleen A. ; Thurston, Archie ; Dambkowski, Carl L. ; York, Kristina A.

Interleukin-13 (IL-13) is a cytokine implicated in the pathophysiology of type 2 inflammatory diseases and is a clinically validated target in atopic dermatitis. APG777 is a humanized IgG1 monoclonal antibody with an optimized pharmacokinetic profile. APG777 has high affinity to IL-13 and includes a triple amino acid modification (the “YTE” modification) in its Fc region that is designed to extend its half-life. The current study examined the safety and potential toxicity of APG777 when given by once-weekly subcutaneous injection for 27 weeks to cynomolgus monkeys, and the potential reversibility of any findings following a 2-month recovery period. Toxicokinetic characteristics of APG777 were also determined. APG777 exhibited dose-proportional systemic exposure, with a half-life of approximately 28 days. No APG777-related adverse effects were noted in clinical observations, body weight, ophthalmology, electrocardiogram readings, neurologic parameters, hematology, coagulation, clinical chemistry, urinalysis, organ weights, or histopathology. Anti-drug antibodies were not detected in any APG777-exposed animals. Drug accumulation was evident over the study duration; however, there were no APG777-related adverse findings in any of the parameters analyzed. The no-observed-adverse-effect level (NOAEL) was 150 mg/kg/week. These findings provide preclinical evidence supporting continued clinical development of APG777 for IL-13-mediated diseases. The extended half-life of APG777 suggests potential benefits in reducing dosing frequency compared with existing IL-13-targeting therapies, which could improve treatment adherence and patient outcomes. The safety and efficacy of APG777 are currently being investigated in a Phase 2 clinical trial (NCT06395948) in patients with moderate-to-severe atopic dermatitis.

2025-11-01·The journal of allergy and clinical immunology. Global

In vitro potency and pharmacokinetics of APG777, a novel anti–IL-13 mAb

Article

作者: Oh, Jason ; Dabora, Rebecca ; Dambkowski, Carl L ; Prentice, Holly ; Zhu, Eric ; Wickman, Grant ; Shaheen, Hussam ; Gandhi, Namita A ; Dillinger, Lukas

Background:

IL-13 plays a key role in the induction and perpetuation of type 2 immune responses associated with the development of atopic dermatitis and other chronic inflammatory diseases. mAbs targeting IL-13 have demonstrated efficacy in IL-13-driven diseases; however, current therapeutics require dosing every 2 to 4 weeks, resulting in significant injection burden for patients. APG777 is a humanized, IgG1 IL-13-targeting mAb that has been engineered to have an optimized pharmacokinetic profile, allowing for less frequent dosing.

Objective:

We sought to investigate the in vitro potency and in vivo pharmacokinetics of APG777.

Methods:

The affinity of APG777 was characterized using surface plasmon resonance; the half-maximal inhibitory concentration (IC₅₀) of APG777 was determined in various in vitro assays measuring inhibition of IL-13 signaling via signal transducer and activator of transcription 6 phosphorylation and chemokine release in relevant cell lines. Pharmacokinetics of APG777 were evaluated in nonhuman primates following a single intravenous or subcutaneous infusion. All studies included lebrikizumab produced based on the publicly available sequence as key comparator.

Results:

APG777 demonstrated a similar in vitro potency across numerous assays compared with lebrikizumab and a 2-fold longer serum half-life following subcutaneous injection in nonhuman primates.

Conclusions:

These data provide evidence in support of the clinical potential of APG777 in diseases where IL-13 signaling is a main driver of the inflammatory response. The prolonged half-life of APG777 may enable less frequent dosing compared with current treatments, which could reduce injection burden and increase compliance. APG777 is currently being investigated in a phase 2 randomized, controlled trial in patients with atopic dermatitis.

231

项与祖米洛基巴特相关的新闻（医药）

2026-06-25

·BioPharmaDive

AbbVie to acquire Apogee, staking nearly $11B on long-acting autoimmune drugs

AbbVie is making its biggest acquisition in years in a bid to expand its portfolio of autoimmune disease drugs, announcing on Monday plans to buy Apogee Therapeutics for nearly $11 billion. The pharmaceutical giant will pay $135.11 per share for Apogee, a roughly 49% premium to the biotechnology company’s closing price on Friday. The acquisition should close in the third quarter of 2026, pending approvals from shareholders and regulatory agencies. The Financial Times first reported news of a pending deal on Friday. The purchase is AbbVie’s largest since taking over Botox maker Allergan in a $63 billion deal in 2019. It also surpasses the company’s big-ticket buyouts of ImmunoGen and Cerevel Therapeutics in 2023, two deals AbbVie used to add medicines for cancer and neurological diseases. For the biotechnology sector, the buyout adds to a particularly active year for company purchases. So far, 32 deals have been struck with at least $50 million in guaranteed upfront payments. Around two thirds of those deals have been worth at least $1 billion and six have eclipsed $5 billion. Both totals are on pace to surpass what’s been seen in every year since at least 2020, according to BioPharma Dive data. In acquiring Apogee, AbbVie is adding to an armamentarium of inflammatory disease medicines that has long been its core focus. That portfolio was long led by Humira, which made more than $200 billion for AbbVie before going off-patent, and now includes newer drugs like Skyrizi and Rinvoq that are used to treat conditions such as psoriasis, Crohn’s disease and eczema. Apogee’s top drug, zumilokibart, is being positioned as a competitor to widely used antibody-based drugs for eczema and asthma, such as Sanofi and Regeneron Pharmaceuticals’ Dupixent. Whereas Dupixent is injected every two weeks, zumilokibart offers the potential for anywhere from two to four injections per year. It also works slightly differently than Dupixent, precisely binding to the inflammatory cytokine IL-13 rather than a receptor shared by IL-13 and a different signaling protein. The result is a drug that might be more potent and convenient than other injections. In its statement, AbbVie noted how a large majority of people with atopic dermatitis still don’t see both relief from itching, as well as improvements in skin clearance. Phase 2 testing showed that about two-thirds of treatment recipients had “significant” skin clearance after 16 weeks, along with “notable improvements” in itching. Those findings, along with a safety profile that’s consistent with other, similar medications, support zumilokibart’s “best-in-class” profile, AbbVie said. Phase 3 testing had been expected to start later this year. Apogee has a pipeline of other longer-lasting immune drugs in earlier testing as well. One, APG273, combines zumilokibart with another antibody that blocks a signaling protein, TSLP, implicated in lung inflammation. Early data suggest that it could be useful in treating asthma and injected either quarterly or twice per year. “Apogee's pipeline adds highly differentiated clinical-stage assets, further expanding our robust immunology portfolio in areas of significant patient need, including atopic dermatitis and asthma,” said AbbVie CEO Robert Michael, in a statement. For Apogee, the buyout is an “ideal and sensible outcome,” but comes “earlier than we would have expected,” wrote RBC Capital Markets analyst Brian Abrahams. To Abrahams, it “remains possible” that other suitors could come forward, as zumilokibart might be a fit for “many other large pharma players,” such as Sanofi or Johnson & Johnson. AbbVie, though, could maximize the drug’s potential to achieve “mega-blockbuster status,” Stifel analyst Alex Thompson added in a separate note. AbbVie is a “natural acquirer” for Apogee and buying the company now could minimize the royalty payments owed by Apogee to Blackstone Life Sciences under a recent financing deal, he wrote. Apogee is one of several immune disease-focused spinouts of antibody drug specialist Paragon Therapeutics. A few others, among them Spyre Therapeutics and Oruka Therapeutics, are now publicly traded and worth billions of dollars. The content above comes from the network. if any infringement, please contact us to modify.

并购免疫疗法临床结果

2026-06-24

·TiPLab

专注于炎症免疫疾病长效抗体疗法的 Apogee Therapeutics

2026 年 6 月 22 日，AbbVie 与 Apogee Therapeutics 宣布达成最终协议，AbbVie 将以约 109 亿美元收购 Apogee，从而获得其多元化的多元化的炎症免疫疾病候选药物管线。Apogee 的领先资产 zumilokibart 是一种靶向 IL-13 的长效皮下注射单抗，正开发用于特应性皮炎、哮喘等适应症。此次收购将强化 AbbVie 现有的免疫学产品组合，并加速其在呼吸系统疾病领域的临床布局。专注于炎症免疫疾病长效抗体疗法的 Apogee Therapeutics by TiPLab 木桃 AbbVie 通过此次收购意在强化下一代免疫管线，应对 Humira 生物类似药竞争以及免疫学重磅药物 Skyrizi（IL23单抗risankizumab）/Rinvoq（JAK抑制剂，乌帕替尼）未来的专利到期（核心活性成分均将于2033年到期）压力。 Apogee 于 2022 年由生命科学投资机构参与创立的，是抗体发现与工程化平台型公司 Paragon Therapeutics 的首个 spinout，其早期核心管线来自 Paragon 的抗体发现平台，并通过战略合作获得一系列抗体项目的独家开发/商业化选择权。 Apogee 的核心价值是把 IL-13、IL-4Rα、OX40L、TSLP 这些已被临床验证或高度验证的免疫炎症靶点，开发为长半衰期抗体 + 组合疗法的策略，以期克服现有疗法的局限性，包括低频给药和提高疗效。特应性皮炎（AD）当前的治疗方案存在局限性，包括：不能治愈、生物制剂注射负担高、儿童患者接受度有限、JAK 抑制剂安全性限制明显、现有靶点机制覆盖（集中在IL-13、IL-4Rα 和 IL-31Rα）仍不够上游和广谱。轻中度AD：以局部治疗为主，包括，外用糖皮质激素、润肤剂、外用钙调神经磷酸酶抑制剂（他克莫司或吡美莫司）、crisaborole、外用 ruxolitinib 等。中重度 AD：单抗已成为首选的一线治疗方案。目前已有四种获得 FDA 批准的单克隆抗体药物，分别是 Dupixent / dupilumab（靶向 IL-4Rα，Regeneron + Sanofi）；Adbry / tralokinumab（靶向 IL-13，LEO Pharma）；Ebglyss / lebrikizumab（靶向 IL-13，Lilly）；Nemluvio / nemolizumab（靶向 IL-31Rα，Galderma）。生物制剂控制不佳者：系统性 JAK 抑制剂，如 Rinvoq / upadacitinib、Cibinqo / abrocitinib，可作为后续选择，但受安全性限制。 Apogee 认为 OX40L 位于比 IL-13 或 IL-4Rα 更上游的炎症通路，理论上可能更广泛影响 Type 1、Type 2 和 Type 3 炎症反应。 Apogee 的管线包括单药疗法和联合疗法，包括 zumilokibart（APG777）、APG279（zumilokibart + APG990）、APG273（zumilokibart + APG333）和 APG808。其候选产品均采用了延长半衰期技术和其他优化特性，包括 YTE（M252Y/S254T/T256E）和 LS （M428L/N434S）修饰等多种延长半衰期技术。主要候选药物 zumilokibart（APG777，用于特应性皮炎、哮喘和嗜酸性食管炎）利用 YTE 氨基酸修饰延长半衰期技术，是一种靶向 IL-13 的皮下注射单抗。 IL-13 主要由活化的 Th2 细胞产生，其产生增加与多种疾病相关，例如特应性皮炎（AD）、哮喘和某些类型的癌症。IL-13 与 IL-13Rα1 结合后招募 IL-4Rα 形成异源二聚体，激活 JAK 相关信号并诱导炎症因子表达。Zumilokibart 旨在阻断异二聚体的形成，从而干扰 IL-13 信号传导。参见：Apogee Therapeutics官网在中重度特应性皮炎 Phase 2 APEX Part B 中，16 周 zumilokibart 中等剂量组达到了主要终点：EASI-75（湿疹面积和严重程度指数评分降低至少 75%）为 65.9%，安慰剂为 23.4%；中等剂量组的关键次要终点也显著优于安慰剂；安全性良好。公司计划将中等剂量推进至 Phase 3。 Zumilokibart 主打“更长给药间隔”（每3个月或6个月给药一次）：在 EASI-75 疗效上接近或优于部分竞品，同时给药间隔显著更长。参见：Apogee Therapeutics官网 APG279 是 zumilokibart + APG990 的组合（用于特应性皮炎），其中 APG990 是一种靶向 OX40L 的皮下注射长效单抗。该组合旨在同时抑制 IL-13 末端 Type 2 炎症和 OX40L 上游 T 细胞激活。 APG273 是 zumilokibart + APG333 的组合（用于哮喘、慢性阻塞性肺病），其中 APG333 是靶向 TSLP 的全人源长效单抗。TSLP 是上皮细胞来源的alarmin家族细胞因子，可激活 TSLPR/IL-7Rα 相关信号，驱动树突细胞、ILC2 等炎症级联。该组合旨在同时覆盖 IL-13 效应通路和 TSLP 介导的上皮 alarmin 启动通路。 APG808 是一种皮下注射的长效单抗，靶向 IL-4Rα（用于哮喘）。APG808 通过阻断 IL-4Rα，可以阻止 IL-13Rα1-IL-4Rα 异二聚体的形成。根据Apogee的披露，围绕 zumilokibart 共有8个专利家族：其中，活性成分授权专利US12358979B2通过bypass途径+ Track One通道快速获得授权，其权利要求1保护靶向IL-13的抗体，限定重链和轻链可变区序列以及包含具有LALA和/或YTE突变的人 IgG1 Fc 区域。后续分案申请US20250368733A1还在审查阶段。 US12358979B2的实施例中，将多个工程化 anti-IL-13 抗体，尤其是 Construct 133 与 lebrikizumab、tralokinumab 等 anti-IL-13 抗体进行比较，也引入 dupilumab 作为 IL-13 通路功能阻断的阳性对照。核心结论是： Construct 133 对人 IL-13 具有低皮摩尔级亲和力； Construct 133 在多项 IL-13 诱导的细胞功能实验（pSTAT6、TARC 分泌和 TF-1 增殖）中达到或接近 dupilumab/lebrikizumab 的抑制水平，并优于 tralokinumab；其与 lebrikizumab 具有高度重叠的 IL-13 表位，同时通过 Fc 长效化获得较 lebrikizumab 更长的 NHP 半衰期。 * 以上文字仅为促进讨论与交流，不构成法律意见或咨询建议。 © 作为一家专业服务公司，TiPLab坚持原创的系统的研究，注重系统性知识积累与专业影响力。欢迎读者个人分享转发，各专业平台媒体如需转载请联系TiPLab获得授权。 TiPLab提供基于研究的核心知识产权服务 FTO：技术商业化实施的侵权风险防范 TiPLab通过对细分技术领域内核心技术和重要专利的长期研究，结合自身在数据检索和分析方面的专长，致力于帮助客户深入了解、积极应对潜在的专利侵权风险。 Due Diligence：商业活动中的知识产权尽职调查在企业许可交易、融资、并购、上市等过程中，TiPLab帮助企业和投资方了解目标技术/产品的专利保护强度及产品商业化过程中潜在的专利侵权风险，从而为商业谈判和决策提供支持依据。 Patenting：全球范围内高价值专利资产的创设 TiPLab熟知全球主要国家和地区的法律实践和细分领域内的前沿技术进展情况，通过前瞻性的专利布局策略，帮助客户通过创设有价值的专利资产而获取、保持和巩固独特的竞争优势。

2026-06-24

·自免药研社

艾伯维誓要重塑全球自免药物竞争格局，再次收购 Apogee Therapeutics

109亿美元豪赌长效II型炎症赛道导语：当地时间 6 月 22 日，全球自免龙头艾伯维（AbbVie，ABBV）官宣全现金收购临床阶段生物技术企业 Apogee Therapeutics（APGE），交易总额 109 亿美元，成为 2026 年全球创新药单笔最大并购、艾伯维近五年规模最大战略布局。这笔针对一款 II 期 IL-13 超长效单抗的百亿级收购，本质是自免赛道巨头直面 Dupixent 垄断、提前卡位下一代长效抗体迭代周期的标志性动作，也折射出全球 II 型炎症药物的竞争逻辑彻底转向给药便捷性差异化竞争。一、📝交易完整条款与二级市场股价异动（一）✅核心交易细则 1.交易对价：每股现金收购价135.11 美元，对应总股权价值 109 亿美元；相较于协议签署前（6 月 18 日）收盘价 90.38 美元溢价49%，对比 6 月初股价区间溢价最高接近 60%。 2.交割安排：交易已获得两家公司董事会全票通过；交割前置条件包含 Apogee 股东大会股东投票通过、全球多国反垄断监管审查落地，预计2026 年第三季度完成全部交割。 3.违约制衡机制：设置双向等额终止费，任意一方触发交易终止条款，需向对方支付3.81 亿美元分手费，锁定交易确定性。 4.资金模式：艾伯维主要通过新增债务融资覆盖收购资金；本次交易仅次于 2019 年 630 亿美元收购艾尔建，为公司历史第二大并购交易。（二）📈收购消息引发股价异动 •Apogee（APGE）：收购消息盘前开盘暴涨约 47.9%，股价快速上行至 132.78 美元，无限贴近 135.11 美元收购对价，二级市场直接认可资产估值逻辑。 •艾伯维（ABBV）：当日股价收涨约 6%~7%，机构普遍判断本次收购补齐免疫管线长期短板，对冲远期业绩压力，长期战略价值明确。 •赛诺菲：盘中出现小幅承压波动，市场直接解读为 Dupixent 迎来重量级长效竞品，长期垄断格局遭遇明确挑战。二、🔍标的基本面拆解：Apogee—— 专注 II 型炎症长效抗体的新锐 Biotech Apogee 2022 年自 Paragon Therapeutics 分拆独立设立，企业定位高度聚焦自身免疫、II 型过敏性炎症长效单抗开发，成长节奏极具资本辨识度：成立仅 7 个月完成 1.69 亿美元大额 B 轮融资，2023 年 7 月登陆纳斯达克募资 3 亿美元，从初创到 IPO 仅用时 7 个月；截至收购前员工总数仅 261 人，无商业化产品，全部价值锚定临床管线资产。 💎核心收购筹码：Zumilokibart（APG777，长效 IL-13 单抗） 1. 🧬分子差异化底层设计靶点为 IL-13（II 型炎症核心驱动细胞因子，特应性皮炎、哮喘、嗜酸性食管炎核心通路）；抗体 Fc 端引入YTE 氨基酸突变，提升与 FcRn 受体结合能力，显著拉长体内半衰期至约 77 天，是本品最核心壁垒，并非靶点创新，而是药代动力学工程化创新。 2. 📊临床进度与公开数据 •适应症布局：中重度特应性皮炎（AD）II 期临床全部完成，公司规划2026 年下半年正式启动全球 III 期注册临床；哮喘、嗜酸性食管炎（EoE）处于 I/II 期探索阶段。 •16 周诱导期关键临床数据（APEX II 期 B 部分）：中剂量组 EASI-75 应答率 65.9%、EASI-90 应答率 47.4%，安慰剂组仅 23.4%、9.3%，统计学差异显著；该数值在公开文献数值层面优于 Dupixent 历史基线数据，未开展头对头直接对照试验，不可直接定义疗效碾压；综合结膜炎不良反应发生率可控，选定该剂量推进 III 期开发。 •52 周长期维持给药数据：诱导期达标患者，后续可选择每 3 个月皮下注射 1 针、最长每 6 个月给药一次维持疗效，长效优势大幅降低注射频次，提升慢病长期治疗依从性。 •商业化规划：若 III 期临床顺利达到终点，预计2029 年提交 FDA 上市申请，对标 Dupixent 冲击 II 型炎症下一代重磅炸弹药物。 🔗管线协同布局：IL-13 双特异性长效抗体矩阵 1.APG279：IL-13+OX40L 双靶点长效单抗，处于 I 期临床，同时阻断炎症启动与淋巴细胞活化通路，拓展难治性炎症适用空间； 2.APG273：IL-13+TSLP 双靶点复方单抗，向上游阻断炎症警报素信号，主攻哮喘、慢阻肺等呼吸道炎症适应症；两条管线围绕 IL-13 核心通路形成梯度布局，实现皮肤病、呼吸炎症跨领域延伸。三、💡自免产业视角：艾伯维收购三大底层战略逻辑逻辑一：🛡️主动对冲核心产品专利周期，筑牢免疫学基本盘艾伯维免疫学为公司第一大收入板块，2025 年板块总营收接近 287 亿美元，占整体总收入近 47%，是企业增长根基： 1.老牌药王 \\ 修美乐（Humira）\\ 专利全面到期，生物类似药持续挤压份额，营收连年大幅下滑； 2.当前增长双支柱：*\Skyrizi（IL-23 单抗）、Rinvoq（乌帕替尼，JAK 抑制剂）\*2025 年合计销售额超 258 亿美元，成为承接 Humira 缺口的主力；两款药物核心物质专利 2033 年到期，艾伯维虽通过专利诉讼和解将 Rinvoq 美国独占期延长至 2037 年，但仍需布局 2030 年后新一代增长管线； 3.本次收购以百亿对价前置锁定 II 型炎症最优长效资产，填补公司在 IL-13 通路空白，承接中长期业绩接力需求。逻辑二：⚔️正面狙击赛诺菲 Dupixent 全球垄断，搭建分层给药产品矩阵 Dupixent（度普利尤单抗，IL-4Rα 单抗）是当前全球自免领域销售额最高单品，2025 年全球销售额超 157 亿欧元，覆盖特应性皮炎、哮喘、鼻息肉、嗜酸性食管炎等八大适应症，在中重度特应性皮炎生物制剂市场占据绝对主导地位，常规给药方案为每 2 周皮下注射一次。收购完成后，艾伯维将形成完整差异化产品梯队： •短效口服方案：Rinvoq（乌帕替尼，口服 JAK 抑制剂，依从性灵活） •中长效注射方案：Skyrizi（IL-23 单抗，银屑病、皮炎主力） •超长周期注射方案：Zumilokibart（3~6 个月给药 IL-13 单抗，慢病长期管理最优选择）依靠给药频次分层实现错位竞争，打破 Dupixent 在 II 型炎症赛道一家独大格局；Dupixent 核心专利保护区间至 2031 年之后，本品 2029 年申报上市，精准卡位竞品独占期末窗口期提前抢占医生与患者心智。逻辑三：🌐补齐呼吸炎症管线短板，拓宽自免疾病版图艾伯维既往免疫学优势集中于银屑病、特应性皮炎等皮肤科适应症，哮喘、嗜酸性食管炎、慢性鼻窦炎伴鼻息肉等 II 型呼吸道炎症布局薄弱；借助 Apogee 整条管线，快速切入空间广阔的呼吸炎症蓝海市场，实现皮肤病 + 呼吸道炎症双向覆盖，完善自免全疾病谱系布局。四、⚖️行业客观辩证分析：百亿收购机遇与潜在风险（一）✅行业标志性意义 1.长效化成为 II 型炎症确定性发展主线：特应性皮炎、哮喘属于终身慢病，注射频次是患者用药依从性核心痛点，3~6 个月超长给药模式是下一代抗体药物核心差异化壁垒，本次百亿收购印证资本与 Big Pharma 对该方向高度共识； 2.中后期自免优质资产估值持续走高：仅 II 期临床阶段候选药斩获 109 亿美元收购对价，反映全球 IL-4/IL-13 通路赛道拥挤、源头优质临床资产稀缺，大型药企加速并购卡位，提前布局 Dupixent 后时代市场格局重塑； 3.工程化改造价值凸显：靶点创新难度攀升，Fc 长效修饰、双特异性抗体等分子优化手段，成为 Biotech 打造 Best-in-class 产品的主流路径。（二）⚠️客观潜在不确定性（避免夸大产品前景） 1.III 期临床成败风险：Zumilokibart 仅完成 II 期数据，III 期大样本临床存在疗效不及预期、新增不良反应、剂量耐受问题等研发不确定性，百亿收购对价本质是对临床成功率的高额赌注； 2.竞品赛道拥挤挤压：全球已有多款长效 IL-4Rα、IL-13 单抗进入临床中后期，礼来、阿斯利康及国内多家创新企业同步布局长效 II 型炎症产品，未来商业化竞争激烈； 3.审批与商业化成本压力：交易交割需应对多国反垄断审查存在延期可能；后续 III 期投入、上市推广、医保准入将持续产生大额资本开支，拉长投资回本周期； 4.非头对头数据局限性：现有 II 期数据仅与安慰剂对照，未和 Dupixent 开展头对头研究，不能直接判定疗效更优，最终市场竞争力仍需头对头临床数据验证。五、📌总结本次 109 亿美元收购不是单一 Biotech 并购个案，而是全球自身免疫药物进入存量竞争、产品迭代周期切换的标志性事件。艾伯维通过重金拿下超长效 IL-13 差异化资产，完成免疫学管线代际储备，直面赛诺菲 Dupixent 垄断格局；对于整个自免创新药行业而言，长效抗体、双特异性抗体将成为未来 5~10 年 II 型炎症药物研发与并购的核心主旋律，慢病给药便捷性正式取代单纯靶点疗效，成为药企争夺市场份额的核心胜负手。信息来源：艾伯维、Apogee 官方合并公告、Apogee 临床试验公开披露文件、赛诺菲 & 艾伯维历年财报。免责声明：本文仅基于公开信息开展产业商业分析，不构成任何投资、药物临床与诊疗建议。跨界突围：Cullinan Therapeutics TCE技术重塑自免治疗格局重磅临床落地定调赛道估值！Cullinan双TCE数据出炉，自免「免疫重置」时代正式落地 2026自免临床重大进展！KT501完成首例RA患者给药，可控型TCE疗法开启精准免疫重置新时代 Kali Therapeutics, Inc：可控型T细胞衔接技术，重塑自身免疫疾病精准治疗赛道从12.3亿美金KT501交易看三特异性TCE价值：自身免疫病下一代治疗技术观察从康诺亚TCE（BCMA_CD3 T细胞衔接器）CM336交易，剖析国产自免创新资产全球化价值兑现全球唯一进入 IgA 肾病临床试验的 BCMA/CD3 T细胞衔接双抗（TCE）自免赛道｜外企篇｜比利时UCB｜自免领域的专科 21.75亿美金交易落地！康诺亚CM336：国产TCE技术改写自免免疫重置格局自免新药｜康方生物古莫奇单抗国内正式获批，国产IL-17A单抗再添银屑病治疗新选择康诺亚生物（Keymed Biosciences，2162.HK）：以双抗与TCE重构全球自免格局自免肾病第一大病 IgAN：溯源、病程、靶点与全球新药研发全盘点自免肾病临床缺口凸显：云顶新耀 (1952.HK) 与 Travere (TVTX) 落地 EVER001 全球权益出海合作肠道菌群：自身免疫病的关键诱因自身免疫性甲状旁腺功能减退症（Autoimmune Hypoparathyroidism, A-HypoPT）美上市Biotech Kyverna核心管线miv-cel新数据出炉！KYSA-6 II期临床结果亮眼，重塑重症肌无力治愈新格局美股自免CAR-T龙头官宣CFO上任！一次简单人事任命，给所有Biotech 创新药企敲醒警钟自免企业速览-外企篇｜Kyverna：全球首款自免CAR-T递交BLA 5月自免新药月报｜全球68款新药换挡！国产2款IL-17单抗同日获批，CAR-T细胞疗法迎来历史性申报节点

100 项与祖米洛基巴特相关的药物交易

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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
中度特应性皮炎	临床2期	美国	Apogee Therapeutics, Inc.	2024-04-29
中度特应性皮炎	临床2期	加拿大	Apogee Therapeutics, Inc.	2024-04-29
中度特应性皮炎	临床2期	捷克	Apogee Therapeutics, Inc.	2024-04-29
中度特应性皮炎	临床2期	法国	Apogee Therapeutics, Inc.	2024-04-29
中度特应性皮炎	临床2期	德国	Apogee Therapeutics, Inc.	2024-04-29
中度特应性皮炎	临床2期	匈牙利	Apogee Therapeutics, Inc.	2024-04-29
中度特应性皮炎	临床2期	波兰	Apogee Therapeutics, Inc.	2024-04-29
中度特应性皮炎	临床2期	西班牙	Apogee Therapeutics, Inc.	2024-04-29
中度特应性皮炎	临床2期	英国	Apogee Therapeutics, Inc.	2024-04-29
重度特应性皮炎	临床2期	美国	Apogee Therapeutics, Inc.	2024-04-29

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临床结果

适应症

分期

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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


NCT06395948 (APXZP002, AAD2026)	临床2期	特应性皮炎	123	APG777 (moderate AD (16≤EASI≤21 or vIGA-AD=3))	襯夢窪遞範選糧膚糧鹽(選艱膚襯遞鑰積衊鏇範) = occurring in ≥5% of APG777-treated participants included noninfective conjunctivitis and upper respiratory tract infection 糧鑰鏇獵遞鏇鬱蓋觸壓 (獵繭壓積醖艱鹽壓積糧 )	积极	2026-03-27
				APG777 (severe AD (EASI>21 or vIGA-AD=4))
NCT06395948 (APEX, AAD2026)	临床2期	特应性皮炎	123	APG777	鬱壓範鏇醖鹽繭夢餘顧(築膚鏇壓襯糧夢艱鑰糧) = occurring in 6 5% of APG777-treated participants included noninfective conjunctivitis and upper respiratory tract infection. 壓夢鑰憲簾糧膚鏇選簾 (製顧選廠繭鹽製遞鑰襯 ) 更多	积极	2026-03-27
				Placebo
NCT06395948 (APEX, Company_Website) 人工标引	临床2期	中度特应性皮炎 \| 重度特应性皮炎	-	Zumilokibart (APG777) 3-month dosing	選觸夢鏇糧範齋蓋願選(鬱製憲壓齋構鬱願觸夢) = 齋簾窪襯鹽鑰鹽獵願鏇鬱築構憲糧糧製選膚觸 (膚襯壓窪艱積齋繭膚廠 ) 更多	积极	2026-03-23
				Zumilokibart (APG777) 6-month dosing	選觸夢鏇糧範齋蓋願選(鬱製憲壓齋構鬱願觸夢) = 鹹積衊繭網鏇糧淵窪齋鬱築構憲糧糧製選膚觸 (膚襯壓窪艱積齋繭膚廠 ) 更多
NCT06395948 (APEX Part A, AAAAI2026)	临床2期	特应性皮炎	123	APG777	鹹餘餘艱淵遞鑰餘廠夢(鬱夢廠網鏇壓鑰齋顧積): P-Value = <0.001 更多	积极	2026-02-27
				Placebo
NCT06395948 (APEX Part A, AAAAI2026)	临床2期	特应性皮炎	123	APG777 (with evidence of type 2 comorbidities)	網淵齋網齋觸積繭窪膚(襯簾襯遞淵艱糧憲願構) = 範膚鏇選夢窪鑰簾蓋選範製餘憲範淵鑰鏇鑰選 (衊範糧鬱艱願壓餘鏇遞 )	积极	2026-02-27
				Placebo (with evidence of type 2 comorbidities)	網淵齋網齋觸積繭窪膚(襯簾襯遞淵艱糧憲願構) = 醖範築餘獵鹹餘觸鹹簾範製餘憲範淵鑰鏇鑰選 (衊範糧鬱艱願壓餘鏇遞 )
NCT06395948 (APEX, GlobeNewswire) 人工标引	临床2期	中度特应性皮炎 \| 重度特应性皮炎 \| 皮炎	123	APG777	鑰壓膚獵觸餘壓淵淵淵(壓鬱簾構顧膚夢鑰憲鑰) = 淵積選醖鏇繭獵鹹鏇範憲艱醖繭淵積築餘憲選 (襯範蓋遞選齋繭糧顧顧 ) 达到更多	积极	2025-07-07
				placebo	鑰壓膚獵觸餘壓淵淵淵(壓鬱簾構顧膚夢鑰憲鑰) = 蓋構蓋膚糧觸襯憲淵艱憲艱醖繭淵積築餘憲選 (襯範蓋遞選齋繭糧顧顧 ) 达到更多
ACTRN12623000786695 (GlobeNewswire) 人工标引	临床1期	-	40	APG777	蓋壓範糧鹽蓋簾艱齋獵(鬱壓蓋選鬱築醖獵壓壓) = 廠餘鑰蓋廠簾製醖淵廠網簾積糧蓋鑰鏇網鏇構 (獵膚窪壓襯餘艱選艱鑰 ) 更多	积极	2024-03-05
				placebo	-
NCT06395948 (APG777, EADV2023)	临床2期	中度特应性皮炎 \| 重度特应性皮炎 IL-13	-	APG777	鹽鹽獵鬱鬱襯壓淵鹽餘(願簾膚糧願鬱願顧範顧) = 蓋製廠遞網衊醖廠鹽淵願鑰觸夢壓艱鬱鏇積簾 (鏇製網鏇鏇製鏇鏇鏇築 )	积极	2023-10-11
				Lebrikizumab	鹽鹽獵鬱鬱襯壓淵鹽餘(願簾膚糧願鬱願顧範顧) = 顧選鬱鹹範糧鹹築顧窪願鑰觸夢壓艱鬱鏇積簾 (鏇製網鏇鏇製鏇鏇鏇築 )