Phase 2, open-label, extension study to evaluate the long-term safety, clinical activity, and pharmacodynamics of briquilimab in participants previously enrolled in a Jasper sponsored CU clinical trial.

开始日期2024-11-26

申办/合作机构

Jasper Therapeutics, Inc.

NCT06592768

/ Terminated临床1期

A Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Briquilimab in Participants With Allergic Asthma

Study JSP-CP-012 is designed as a proof of concept, parallel-group, single dose, double blind, placebo-controlled study using an allergen challenge model. A single dose proof of concept approach at a dose level shown to be biologically active should inform the impact of briquilimab on allergic asthma as compared to placebo while minimizing exposure to participants, in a new indication.

开始日期2024-11-26

申办/合作机构

Jasper Therapeutics, Inc.

NCT06353971

/ Terminated临床1/2期

A Phase 1b/2a, Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment With H1- Antihistamines

This is an open-label, single ascending dose Phase 1b/2a trial to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with Cold Urticaria (ColdU) or Symptomatic Dermographism (SD), who remain symptomatic despite treatment with H1 antihistamines. The trial will explore three ascending dose levels which will be tested in three sequential cohorts.

开始日期2024-03-18

申办/合作机构

Jasper Therapeutics, Inc.

100 项与布利奎利单抗相关的临床结果

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100 项与布利奎利单抗相关的转化医学

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100 项与布利奎利单抗相关的专利（医药）

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项与布利奎利单抗相关的文献（医药）

2026-06-01·JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Mast cell depletion and repopulation dynamics define briquilimab efficacy in a mouse model of allergic asthma

Letter

作者: Nerkar, Revati ; Ratia, Sara ; Yu, Mang ; Meneses, Karl ; Kattel, Sambidhan ; Pang, Wendy W

2026-05-28·BLOOD

Nonmyeloablative conditioning combined with the anti-CD117 antibody briquilimab in older adults with high-risk AML and MDS

Article

作者: Long-Boyle, Janel ; Yanagiba, Chikako ; Pang, Wendy W. ; Shiraz, Parveen ; Le, Anne ; Arulprakasam, Jeyakavitha ; Lee, Catherine J. ; Gandhi, Arpita ; Scott, Bart L. ; Varma, Ankur ; Artz, Andrew S. ; Muffly, Lori ; Shizuru, Judith A. ; Kwon, Hye-sook ; Youn, Minyoung ; Patel, Sagar S.

Abstract:

Briquilimab is a monoclonal antibody inhibiting stem cell factor (SCF) binding to CD117 (c-Kit). Based on preclinical data demonstrating the antibody clears hematopoietic stem and progenitor cells (HSPC) and myeloid malignant cells, we conducted a phase 1 trial examining briquilimab plus nonmyeloablative fludarabine (Flu) and total body irradiation (TBI) as conditioning for older adults with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) undergoing matched donor allogeneic hematopoietic cell transplantation (HCT). Briquilimab was infused 10 to 14 days before transplant day (TD) 0; Flu 30 mg/m2 and TBI 2 to 3 Gy were administered on TD −4 to −2 and TD0, respectively. Graft-versus-host disease prophylaxis consisted of tacrolimus, sirolimus, and mycophenolate mofetil. Thirty-two patients enrolled (n = 13 AML in complete remission [CR]; n = 3 AML in relapse; n = 16 MDS). Median age was 70 years, and most had detectable measurable residual disease (MRD) at screening. There were no briquilimab infusion reactions, dose-limiting toxicities, or primary graft failure events; briquilimab clearance was predictable across patients. Among the AML in CR cohort, 1-year event-free survival (EFS) was 69.2%; 1-year overall survival (OS) was 75%. Among the MDS cohort, 1-year EFS was 53.8%; 1-year OS was 76.4%. One of 3 patients with AML in relapse experienced a transient response. Marrow samples obtained before and after briquilimab and before Flu/TBI demonstrated AML/MDS HSPC depletion (mean, 62.4% ± 22.7%) with resultant threefold increase in serum SCF. In summary, we demonstrate the feasibility, safety, and proof of concept of CD117 targeting with briquilimab as HCT conditioning for AML/MDS. The trial was registered at www.clinicaltrials.gov as NCT04429191.

2026-04-01·ALLERGY

Human KIT Antibody Briquilimab Diminishes Anaphylactic Responses in Mice Expressing Chimeric Human‐Mouse KIT

Letter

作者: Pang, Wendy W. ; Romo, Andrea R. ; Kwan, Cheryl ; Ji, Allison ; Ratia, Sara ; Kattel, Sambidhan ; Sharma, Ajay ; Meneses, Karl ; Kwon, Hye‐Sook ; Nerkar, Revati ; Wells, Andrew ; Chang, Charles A. ; Yu, Mang ; Youn, Minyoung ; Lee, Song Eun

175

项与布利奎利单抗相关的新闻（医药）

2026-09-15

·BioSpace

Jasper Therapeutics Announces Key Regulatory and Clinical Appointments

Lisa Pitt, Pharm.D., M.S.J. appointed Senior Vice President, Regulatory Affairs Shiguang Liu, M.D., Ph.D. appointed Vice President, Clinical Development REDWOOD CITY, Calif., Sept. 15, 2026 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (“Jasper”), a clinical stage biotechnology company focused on the design and development of innovative therapies to treat immune-mediated diseases, today announced the appointments of Lisa Pitt, Pharm.D., M.S.J. as Senior Vice President, Regulatory Affairs and Shiguang Liu, M.D., Ph.D. as Vice President, Clinical Development. “We are excited to have Lisa and Shiguang join us at Jasper following our merger with Kira Pharmaceuticals,” said Jeet Mahal, President and Chief Executive Officer of Jasper. “Lisa’s experience in regulatory affairs at multiple biotech companies and the FDA, along with Shiguang’s expertise in clinical development in rare diseases in renal and metabolic disorders are key additions as we move forward with the development of vensobafusp alfa (KP104), briquilimab and KP701 across a number of immune diseases.” Dr. Pitt brings over 25 years of experience in leading regulatory and medical affairs across both the industry and at the U.S. Food and Drug Administration (FDA). Most recently, she served as Vice President, Regulatory Affairs at Aiolos Bio prior to its acquisition by GlaxoSmithKline. Prior to that, she held regulatory affairs leadership roles at NorthSea Therapeutics, Horizon Therapeutics, and Viela Bio prior to its acquisition by Horizon Therapeutics. Dr. Pitt served as Senior Regulatory Health Project Manager at the FDA’s Center for Drug Evaluation & Research in the former Division of Gastroenterology and Inborn Errors Products, where she managed the review of Investigation New Drug (IND), New Drug Application (NDA), and Biologic License Application (BLA) submissions. Earlier in her career, she served in Regulatory Affairs roles at AstraZeneca, PAREXEL Consulting, and Novartis. She started her career in laboratory quality assurance roles at Alpharma and Cambridge Biotech. Dr. Pitt received her Pharm.D. from the University of Maryland School of Pharmacy, an M.S.J. from Seton Hall Law School, and a Bachelor degree in Biological Sciences from the University of Delaware, and completed a post-doctoral clinical pharmacy fellowship at Novartis. Dr. Liu joins after spending over a decade of progressive leadership roles in research and development, pharmacovigilance, and clinical development at Sanofi. Most recently, he served as Clinical Lead and Senior Clinical Research Director with a focus on rare diseases in renal and metabolic disorders and leadership in late-stage clinical trials and regulatory submissions. Prior to joining the biopharmaceutical industry, Dr. Liu held several academic appointments, including Assistant Professor at The Kidney Institute at the University of Kansas Medical Center, research faculty at the Duke University School of Medicine, and Visiting Fellow at the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). Earlier in his career, he was an Associate Professor and Attending Physician at the First Affiliated Hospital of Zhengzhou University Medical School, where he also completed his residency training. Dr. Liu received his M.D. from Zhengzhou University Medical School as well as an M.S. in Medicine and a Ph.D. in Cell Biology from the Chinese Academy of Medical Sciences and Peking Union Medical College. Material Inducement Grants Jasper also announced that on September 14, 2026, it granted three new employees options to purchase an aggregate of 243,000 shares of voting common stock (the “Options”) as material inducements to each employee’s employment with Jasper in accordance with Nasdaq Listing Rule 5635(c)(4). The Options were granted pursuant to the Jasper Therapeutics, Inc. Amended and Restated 2022 Inducement Equity Incentive Plan, which was approved by the compensation committee of Jasper’s board of directors on March 14, 2022 and amended and restated on June 2, 2023. The exercise price of each Option is $0.6328. Each Option will vest over four years, with 25% of the total number of shares vesting on the one-year anniversary of the date of commencement of such employee’s employment with Jasper and 1/48th of the total number of shares subject to each Option vesting monthly thereafter, subject in each case to such employee’s continued service to Jasper on each vesting date. About Jasper Jasper is a clinical stage biotechnology company focused on the design and development of innovative therapies to treat immune-mediated diseases. Jasper is advancing a pipeline of medicines including KP-104, briquilimab, and KP-701. KP-104 is a potential best-in-class dual-complement inhibitor that has demonstrated positive outcomes in paroxysmal nocturnal hemoglobinuria (PNH) and is under evaluation in other high unmet need nephrology disorders. Briquilimab is an anti-KIT antibody which has demonstrated positive clinical results both as a conditioning agent for stem cell transplant and mast cell mediated diseases such as chronic urticarias and allergic asthma. KP-701, a novel, dual-acting anti-CD79BxCD32B monoclonal antibody (mAb) for autoantibody-mediated disorders currently advancing to the clinic. Contacts: Alex Gray (investors) Jasper Therapeutics 650-549-1454 agray@jaspertx.com Argot Partners (investors and media) kira@argotpartners.com

2026-09-09

·BioSpace

Jasper Therapeutics to Present at the H.C. Wainwright 28th Annual Global Investment Conference

REDWOOD CITY, Calif., Sept. 09, 2026 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (“Jasper”), a clinical stage biotechnology company focused on the design and development of innovative therapies to treat immune-mediated diseases, today announced that management will participate at the H.C. Wainwright 28 th Annual Global Investment Conference, taking place September 14-16, 2026 in New York, NY. H.C. Wainwright 28 th Annual Global Investment Conference Presentation Date/Time: Wednesday, September 16, 2026; 8:00 AM ET Presentation Format: Fireside Chat A live webcast of the fireside chat will be available on the News & Events – Events page of Jasper's Investor Relations website. An archived replay will be available on Jasper's website for 30 days following the live broadcast. About Jasper Jasper is a clinical stage biotechnology company focused on the design and development of innovative therapies to treat immune-mediated diseases. Jasper is advancing a pipeline of medicines including KP-104, briquilimab, and KP-701. KP-104 is a potential best-in-class dual-complement inhibitor that has demonstrated positive outcomes in paroxysmal nocturnal hemoglobinuria (PNH) and is under evaluation in other high unmet need nephrology disorders. Briquilimab is an anti-KIT antibody which has demonstrated positive clinical results both as a conditioning agent for stem cell transplant and mast cell mediated diseases such as chronic urticarias and allergic asthma. KP-701, a novel, dual-acting anti-CD79BxCD32B monoclonal antibody (mAb) for autoantibody-mediated disorders currently advancing to the clinic. Contacts: Alex Gray (investors) Jasper Therapeutics 650-549-1454 agray@jaspertx.com Argot Partners (investors and media) kira@argotpartners.com

临床结果

2026-08-29

·QQ浏览器

四家NewCO赴美上市，医药出海迎来丰收期

2026年7月，在生物医药领域，有2家公司以IPO的方式赴美上市，1家公司以SPAC形式上市，5家公司宣布以借壳形式上市，1家公司二次上市。一、IPO上市今年7月，共有两家生物医药公司以IPO形式上市。1、Apnimed(NASDAQ:APMD)7月31日，Apnimed正式登陆纳斯达克，发行价为16美元，发行规模为1200万股，募集资金1.92亿美元。Apnimed成立于2017年，专注于为阻塞性睡眠呼吸暂停（OSA）及其他睡眠相关呼吸障碍开发创新口服药物，曾入选2023年Fierce15药企。阻塞性睡眠呼吸暂停（OSA）是最常见的睡眠相关呼吸障碍类型，但在过去的40多年间，治疗方式却一直没有实质性的改善，目前的治疗方式包括睡眠时佩戴“通气”装置、用牙套将下颚向前推，以及选择手术。Apnimed只有一条管线：AD109，这是一种包含具选择性的去甲肾上腺素再摄取抑制剂托莫西汀（atomoxetine）与抗毒蕈碱aroxybutynin的组合配方，靶向OSA关键的神经通路，活化上呼吸道扩张肌，采用一天一次，睡前口服的给药方式，可改善OSA现有疗法耐受性低、具有侵入性等局限。目前，AD109已完成两项关键3期临床试验（SynAIRgy和LunAIRo），覆盖约1300名轻、中、重度OSA患者，两项试验均达到主要终点。两项试验的AHI降幅数据高度一致：SynAIRgy为55.6%，LunAIRo为46.8%，交叉验证了药物的可靠效果。此外，AD109还FDA授予的快速通道资格认定，具备成为“first-in-class”疗法的潜力。公司创始人Larry Miller是一位Biotech老兵，曾经创办了Macrolide、HPR、Avicenna、PharMetrics、ImpactRx、Serenex、Optio Research、Tetraphase和Activate等9家Biotech公司，其中两家完成的IPO上市，7家公司被收购，亦曾创办了专注于医疗领域投资的Mediphase基金。现任CEO Kevin Lind 曾担任Longboard Pharmaceuticals（被灵北收购）的总裁兼首席执行官。2、Scribe Therapeutics(NASDAQ:SCTX)7月24日，Scribe Therapeutics在纳斯达克上市，IPO发行价格为15美元，发行858万股，募资规模达1.29亿美元。在IPO发行中，赛诺菲认购50万股，而老股东礼来继续增持，以维持10.9%的持股。Scribe Therapeutics由Jennifer Doudna与CEO Benjamin Oakes等人于2017年联合创立，致力于将CRISPR技术应用于常见疾病的体内治疗。公司的核心技术平台名为CRISPR by Design ——一种数据驱动的迭代工程化方法，将自然界中存在的CRISPR系统工程化为活性高、特异性强且具备可递送性的基因药物工具。与传统的CRISPR基因编辑不同，Scribe的技术平台采用表观遗传沉默（epigenetic silencing）策略，通过工程化改造的CRISPR系统靶向特定基因，在不永久性切割或改变DNA的前提下对基因表达进行调控。该公司表示这一方法在安全性上具有显著优势，可扩大适用患者群体。基于该技术平台，Scribe开发了多款候选药物：STX-1150：一款靶向PCSK9的表观遗传沉默疗法。通过表观遗传学机制沉默PCSK9基因并降低低密度脂蛋白胆固醇（LDL-C）水平，采用具有肝脏趋向性的脂质纳米颗粒（LNP）进行包封递送。STX-1150旨在通过单次给药实现持久的治疗获益，目前，已在澳大利亚进行临床试验。STX-1200：靶向LPA基因的Lp(a) 降低疗法。STX-1200 旨在通过选择性修饰肝细胞中的 LPA 基因，从根源上阻断疾病的遗传学成因，从而防止脂蛋白 (a) [Lp(a)] 水平升高。STX-1400：靶向APOC3的甘油三酯降低疗法。通过编辑APOC3基因，STX-1400有望实现具有临床意义且持久的甘油三酯降低，从而覆盖由甘油三酯驱动的广泛疾病谱，包括家族性乳糜微粒血症综合征（FCS）和严重高甘油三酯血症（SHTG），使其具备「一药多治」（pipeline within a drug）的巨大潜力。对外合作方面，公司先后与多家大药企达成合作：2023年5月，Scribe宣布与礼来全资子公司Prevail Therapeutics达成战略合作，将Scribe的CRISPR XE技术授权给Prevail，用于开发针对严重神经疾病和神经肌肉疾病的体内CRISPR基因疗法。Scribe获得7500万美元，有资格获得超过15亿美元的开发及商业化里程碑付款；2023年7月，Scribe宣布与赛诺菲扩大合作关系，在既有体外自然杀伤（NK）细胞疗法合作（针对癌症）的基础上，新增体内基因编辑方向，首选目标疾病为镰状细胞病及其他基因组疾病。Scribe获得4000万美元首付款；有资格获得超过12亿美元的开发及商业化里程碑付款。二、SPAC上市7月，有1家公司宣布或完成SPAC上市。1、Research Alliance III（NASDAQ：RACC）7月27日，Oak Hill Bio宣布与SPAC公司RACC协议。合并后的公司在纳斯达克资本市场上市交易，股票代码为 “OAKH”。合并的同时，Oak Hill Bio宣布以每股10美元的价格完成1亿美元PIPE融资，融资由RA Capital领投，Balyasny、Janus Henderson、KCap Biotechnology、venBio，ADAR1 Capital、Affinity、Ally Bridge、BVF、Great Point、Logos Capital、SilverArc Capital、Trails Edge Capital Partners等机构跟投。而在今年6月1日，Oak Hill Bio宣布完成3250万美元A轮融资。Oak Hill Bio是一家专注于罕见病反义寡核苷酸 (ASO) 疗法的药企。目前，Oak Hill Bio仅有一款针对Angelman syndrome综合征的药物Rugonersen。Rugonersen (RO7248824) 最早由罗氏开发 (2025年4月Oak公司取得独家开发和商业化权利)，是一种靶向UBE3A-ATS的反义寡核苷酸 (ASO) 疗法，其核心作用机制在于避开母源基因缺陷，直接作用于被基因组印迹沉默的父源UBE3A基因，促使其重新激活并表达具备完整功能的UBE3A蛋白，从而在最根本的病因层面修复神经元损伤。目前，Rugonersen已经开启了名为BEACON的Ⅲ期临床试验，主要研究结果将在2029年初披露。公司CEO Marc Schegerin曾担任Morphic Therapeutic（被礼来以32亿美元收购）的首席运营官兼首席财务官，ArQule（被默沙东以27亿美元收购）的首席财务官兼战略负责人，在进入医药行业前，他曾在高盛、花旗集团、美银美林的医疗保健投资银行部担任高级副总裁等要职。三、反向并购上市（Reverse Merger）7月，共有5家公司采用反向并购形式上市，比上月还多出1家，今年是Biotech反向并购上市大年。1、NextCure(NASDAQ:NXTC)7月14日，Avere Therapeutics与美股上市公司NextCure（NASDAQ：NXTC）订立合并协议，合并后公司以前者名称运营，并以股票代码“AVRX”进行交易。Avere Therapeutics同时宣布完成3.2亿美元的PIPE融资，本轮融资由Fairmount和翰森制药领投，Venrock Healthcare Capital Partners、General Atlantic、Janus Henderson、Wellington Management、博裕资本、 Sirona Capital、T. Rowe Price、RTW Investments、Sirenia Capital 、Logos Capital、Redmile、Affinity Asset Advisors、Balyasny Asset、Wedbush Healthcare Partners等机构跟投。Avere Therapeutics是一家专注于自免领域的药物开发公司，其核心管线来源于重要药企的授权：2026年6月15日，翰森制药宣布与Avere订立独家许可协议。根据许可协议，翰森制药授予Avere在全球（不包括中国内地、香港、澳门及台湾）开发、生产及商业化口服环肽IL-23拮抗剂HS-20118(AVR-001)的独家许可。翰森制药有权收取合共1.2亿美元首付款，最高21.8亿美元与开发及销售相关的里程碑付款，以及基于销售额的中个位数至低双位数百分比之特许权使用费。AVR-001是一种选择性靶向IL-23通路的口服肽类拮抗剂。在自身免疫病（特别是银屑病）领域，IL-23/IL-17炎症轴已经被诸多重磅单抗（如Starky、Tremfya等生物制剂）验证。AVR-001真正吸引美国顶流资本的商业叙事在于：它是口服剂型，且经过分子改造后半衰期长达100小时（在SID 2026会议上披露的终末半衰期甚至达6到7天），完美支持“每周口服一次”的给药频率。AVR-001的竞争对手是强生与Protagonist联合开发的icotrokinra。该药已于2026年3月获得 FDA 批准上市，成为全球首个也是目前唯一一个获批的口服抗IL-23R肽类疗法，其短板在于每日给药一次。按照计划，Avere将于2027年初启动全球银屑病Phase 2b临床，并在2028年上半年读出数据。Avere由一支经验丰富的执行团队领导，该团队指导Akero Therapeutics（NASDAQ：AKRO）从pre-IPO到2025年12月以高达52亿美元的价格出售给诺和诺德。该团队由首席执行官、总裁兼董事会主席Andrew Cheng博士领导，其中包括首席开发官Kitty Yale；首席财务官兼企业发展主管William White以及总法律顾问Brett Pletcher。2、Synlogic(PINK:SYBX)7月29日，美股Synlogic宣布与Caldera Therapeutics签署合并协议，合并后公司以后者名称运营，计划在纳斯达克上市，代码为“CAL在合并的同时，Caldera Therapeutics宣布获得一项2.78亿美元的私募融资，投资方包括贝恩资本、TCGX、Atlas Venture、venBio、Omega、黑石、 Henderson、Sirenia Capital、维梧资本。Caldera Therapeutics是一家致力于开发炎症性肠病（IBD）及其他免疫介导疾病的创新疗法的企业。公司采取license-in模式，于2025年4月，与荃信生物就临床前阶段长效自免双抗QX030N签订授权许可协议，Caldera获得开发及商业化QX030N的全球独家许可。药物授权的对价是Caldera Therapeutics公司向荃信生物支付1000万的首付款，以及24.88%的公司股权，最多5.45亿美元的里程碑付款；此外，荃信生物有权在QX030N首次商业销售后的一段特定时间内收取销售净额的分级特许权使用费。公司唯一的药物CLD-423（QX030N）是一款双特异性抗体，同时靶向IL-23p19和TL1A。这两个靶点在IBD领域均已被临床验证，是调控参与炎症性肠病发病机制的关键通路。当前IBD市场中，单靶点生物制剂已高度竞争，疗效提升空间逐步逼近“天花板”。其中IL-23通路已被多家跨国药企成功商业化，包括礼来的 Omvoh 、强生的Tremfya 以及艾伯维的Skyrizi。而TL1A则在近两年成为IBD领域最受关注的新兴靶点之一，罗氏以高价收购Telavant、赛诺菲与Teva在中期临床中的积极数据，均显著提升了该通路的行业认可度。在此背景下，通过在一个分子中整合两个关键通路，以期提升疗效并降低联合用药复杂性，正逐渐成为下一代IBD药物的重要方向。从机制上看，这一设计并非“激进创新”，而是在成熟靶点。出身于陆军中尉的公司CEO Praveen Tipirneni拥有丰富的行业经验，曾担任Morphic Therapeutic的CEO（被礼来32亿美元收购）， Cubist Pharmaceuticals的副总裁（被默克以90亿美元收购）。今年以来，尧唐生物的NewCo Serapha Bio借壳Boundless Bio、金赛药业NewCo Yarrow借壳Vyne Therapeutics、翰森NewCo Avere同样通过借壳NextCure上市，赴美借壳上市已经成为国内药企NewCo公司的重要退出途径。3、Jasper(NASDAQ:JSPR)7月16日，Kira Pharmaceuticals宣布与美股上市公司JSPR达成合并协议，合并后公司以前者名称运营，并以股票代码“JSPR”进行交易。按完全稀释基础计算，收购前Jasper股东持有约6.68%，科越股东持有约49.86%，私募投资者持有约43.46%。在合并的同时，Kira Pharmaceuticals宣布获得一项1.32亿美元的私募融资，本次融资由Affinity Asset与Ikarian Capital共同牵头,参与方包括Columbia Threadneedle、Sirenia Capital、Brahma Capital、 Balyasny Asset、SilverArc Capital、Squadron Capital、Nazare、Mirador Therapeutics等机构跟投。Kira Pharmaceuticals是一家由华人科学家创立的补体药物公司，公司目前有三款在研药物：KP-104(Vensobafusp alfa)：一款准备进入临床2/3期研究的双功能生物制剂，同时靶向补体级联反应中的旁路途径和终末途径。公司预计将于2026年第四季度公布正在进行的罕见肾病适应症2期篮式试验第一阶段的中期数据。Briquilimab:一款处于后期开发阶段、潜在同类最优的抗KIT抗体。基于在SCID适应症中获得的积极长期数据，公司正推进与FDA召开BLA 前会议的相关工作，并预计于2027年第一季度公布后续计划。KP-701:一款处于临床前阶段、靶向B细胞受体的疗法，预计明年初提交IND。此外，Kira Pharmaceuticals将其长效抗C5a单克隆抗体KP-301及小分子C5a受体拮抗剂KP-402对外授权给Mirador Therapeutics。本次交易将带来1200万美元的首付款, 以及潜在的开发和销售里程碑付款。4、Processa (NASDAQ:PCSA)7月29日，Vidya Therapeutics宣布与美股上市公司Processa达成合并协议。在合并的同时，进行一笔2亿美元的私募融资，投资人包括贝恩资本生命科学、Janus Henderson、RA Capital、SilverArc Capital、ADAR1 Capital、Cormorant、Integral Health、Marshall Wace、Octagon Capital、Soleus Capital等机构。Vidya Therapeutics是一家BTK抑制剂药物研发公司，其核心药物为VT-7208。VT-7208是下一代中枢神经系统渗透共价BTK抑制剂，旨在实现强效、高度选择性和持久的BTK抑制，其临床前和1期数据支持使用比早期BTKi更低的剂量。VT-7208的选择性特征也被设计为尽量减少脱靶激酶活性，Vidya认为与早期的BTKi相比，这可能会降低肝毒性风险。VT-7208聚焦食物过敏、慢性自发性荨麻疹和复发型多发性硬化症三大适应症。值得注意的是，诺华的remibrutinib（Rhapsido）于2025年10月成为首个获FDA批准用于免疫适应症的BTK抑制剂，适应症正是慢性自发性荨麻疹。VT-7208锁定的三条赛道与Rhapsido高度重合，正面竞争意图明确。Vidya计划并行推进三项Ⅱ期概念验证研究：食物过敏和CSU于今年下半年启动，MS于2027年上半年启动，数据读出时间分别对应2027年下半年、2028年上半年和2028年下半年。5、Chemomab(NASDAQ:CMMB)7月8日，Scipher Medicine宣布与美股上市公司CMMB达成合并协议，合并完成后，原Scipher的股东将持有合并后公司约68%的股份，原Chemomab股东将持有约32%的股份，并继续以股票代码“SCIP”上市。在合并的同时，Scipher Medicine宣布完成一笔3000万美元的私募融资，本轮融资由Northpond Ventures牵头、Khosla Ventures、Blue Owl Healthcare Opportunities、Neuberger Berman（路博迈）等机构跟投。Scipher Medicine成立于2014 年，是一家专注于自身免疫性与炎症性疾病领域的精准免疫学及AI医学的前沿企业。公司基于系统生物学与人类蛋白质相互作用网络，利用独家的算法分析大样本患者的多组学（Multi-omics）数据，揭示复杂疾病的分子亚型及驱动网络，一方面用于预测患者对特定药物的治疗响应，另一方面用于从海量数据中挖掘未被满足需求的极具潜力的药物靶点。公司产品PrismRA®是目前全球首个且唯一获美国Centers for Medicare & Medicaid Services覆盖报销的类风湿关节炎分子诊断测试。该测试通过分析血液中的基因表达谱，能够精准预测RA患者是否对常用的TNFi（肿瘤坏死因子抑制剂，如阿达木单抗等）产生耐药或无效，从而指导医生在初始阶段即选择更合适的靶向药物，避免试错治疗。被借壳的上市公司Chemomab，其核心药物Nebokitug是一款首创抗CCL24单克隆抗体，已在多项临床研究中展现出优异的安全性和对纤维化/炎症标志物的改善作用。此次借壳上市，不仅是更换上市主体，而且Scipher与Nebokitug在多个层次有促进作用：AI赋能靶点发现：Scipher的AI平台独立验证CCL24是RA排名第一的治疗靶点，并开发了多组学特征标签，用于筛选最有可能从Nebokitug治疗中获益的患者。双重机制优势：Nebokitug通过阻断趋化因子CCL24，同时靶向炎症与纤维化两大病理过程，这是现有RA药物未能触及的领域。精准入组：即将开展的II期试验将利用Scipher已获CMS医保批准的PrismRA®检测指导患者入组，大幅降低临床失败风险。Scipher Medicine在一级市场累计融资金额超过2.3亿美元，吸引了Cowen Healthcare、Hitachi Ventures、Laurion Capital、Kaiser Permanente等机构的投资。四、二次上市（seconary listing）1、Vicore Pharma(NASDAQ:VCRE)7月6日，瑞典斯德哥尔摩交易所上市的生物医药公司Vicore Pharma在美国纳斯达克交易所二次上市。Vicore Pharma专注于针对罕见呼吸系统疾病及纤维化疾病开发全新作用机制的创新药物，主要方向为血管紧张素II型2受体激动剂（ATRAGs），其研发逻辑是通过激活组织内源性修复通路，可能超越单纯的纤维化抑制，实现肺功能的恢复。公司核心药物Buloxibutid是一种高选择性、口服的小分子AT2R激动剂，用于治疗特发性肺纤维化（IPF），目前正处于全球2b期临床试验阶段。在此前的2a期临床试验中，Buloxibutid展现出了罕见的“肺功能改善/恢复”疗效，颠覆了现有标准疗法仅能“延缓肺功能下降”的局限，且安全性与耐受性良好。该药已获得FDA与EMA的罕见病药资格认定。尽管多家制药巨头有产品处于更晚期阶段，但其疗效目标主要集中于“减缓衰退”。Buloxibutid凭借其上游修复肺泡上皮细胞的独特机制，如果其关键性2b期ASPIRE试验数据达到预期，则公司市值会有较大提升空间。【免责声明】

IPO基因疗法临床3期

100 项与布利奎利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12540	-	-	-

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
重症联合型免疫缺陷	临床3期	美国	Jasper Therapeutics, Inc.	-
慢性荨麻疹	临床2期	美国	Jasper Therapeutics, Inc.	2024-11-26
慢性荨麻疹	临床2期	德国	Jasper Therapeutics, Inc.	2024-11-26
急性胸部综合征	临床2期	美国	National Heart, Lung & Blood Institute	2022-05-12
β地中海贫血	临床2期	美国	National Heart, Lung & Blood Institute	2022-05-12
镰状细胞遗传性状	临床2期	美国	National Heart, Lung & Blood Institute	2022-05-12
腺苷脱氨酶缺乏	临床2期	美国	Jasper Therapeutics, Inc.	2017-03-20
网状细胞发育不全	临床2期	美国	Jasper Therapeutics, Inc.	2017-03-20
镰状细胞血症	临床2期	美国	Jasper Therapeutics, Inc.	-
过敏性哮喘	临床1期	加拿大	Jasper Therapeutics, Inc.	2024-11-26

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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


NCT05907746 (CTgov)	临床2期	GATA2缺陷 \| 免疫缺陷综合征	13	Total Body Irradiation+Fludarabine+Post-Transplant Cyclophosphamide+Tacrolimus+mycophenolate mofetil+Briquilimab (Arm A -Briquilimab, Fludarabine, 200 Centigray (cGy) Total Body Irradiation)	顧糧醖鏇顧獵壓膚繭製 = 範範醖範鹽網選鏇鏇鏇齋顧網選夢鏇齋廠簾襯 (糧艱蓋構簾壓齋醖憲築, 憲築廠願艱繭齋壓醖築 ~ 蓋膚夢衊繭構糧襯鏇憲) 更多	-	2026-05-29
				Total Body Irradiation+Fludarabine+Post-Transplant Cyclophosphamide+Tacrolimus+mycophenolate mofetil+Briquilimab (Arm B - Briquilimab, Fludarabine, Cyclophosphamide, 200 Centigray (cGy) Total Body Irradiation)	顧糧醖鏇顧獵壓膚繭製 = 觸繭鏇鹽壓製選選糧顧齋顧網選夢鏇齋廠簾襯 (糧艱蓋構簾壓齋醖憲築, 憲範鏇鏇鏇鑰築艱網齋 ~ 齋艱艱膚糧餘餘壓積積) 更多
NCT06145282 (CTgov)	临床1/2期	急性胸部综合征 \| 镰状细胞血症	6	Cyclophosphamide+Abatacept+Sirolimus+Briquilimab (PBSC Transplant With 50 mg/kg Post-transplant Cyclophosphamide (PT- Cy))	壓選繭製選餘範繭鹽膚 = 選獵獵網壓艱簾積鹽鬱蓋廠獵餘範簾構選願選 (網選艱積襯鹽鏇糧窪製, 鹹鹹觸餘網蓋齋觸夢鑰 ~ 壓遞鏇醖築襯齋鹽製鹹) 更多	-	2026-04-29
				Cyclophosphamide+Abatacept+Sirolimus+Briquilimab (PBSC Transplant With 100 mg/kg Post-transplant Cyclophosphamide (PT- Cy))	壓選繭製選餘範繭鹽膚 = 製膚艱製膚壓餘遞遞遞蓋廠獵餘範簾構選願選 (網選艱積襯鹽鏇糧窪製, 築艱膚範夢觸鑰築衊構 ~ 願淵簾糧膚夢顧醖鹽淵) 更多
NCT05907746 (EBMT2026)	临床2期	GATA2缺陷 GATA2	11	Briquilimab+nonmyeloablative conditioning	餘鑰鑰網繭淵構鹽淵製(鏇壓鹽糧壓廠淵願淵鹽) = One patient had progression of Mycobacterium abscessus infection during conditioning. Otherwise, conditioning was well tolerated, and there were no infusion toxicities or serious adverse events attributed to briquilimab. 鏇繭壓構網遞醖艱壓鹹 (淵齋鑰窪壓鑰積鏇鹹選 )	积极	2026-03-22
NCT06162728 (BEACON, Company_Website) 人工标引	临床1/2期	慢性荨麻疹	29	briquilimab 240 mg+360 mg	繭鹹壓製壓壓窪壓鹽簾(襯簾製壓範選鬱鑰糧鏇) = 壓鑰窪憲構選壓鹽膚繭膚鑰鏇淵衊觸襯觸艱壓 (窪鑰憲廠顧蓋壓餘廠願 ) 更多	积极	2025-08-13
				briquilimab 180mg Q8W	繭鹹壓製壓壓窪壓鹽簾(襯簾製壓範選鬱鑰糧鏇) = 醖繭淵鏇選糧鬱繭鑰築膚鑰鏇淵衊觸襯觸艱壓 (窪鑰憲廠顧蓋壓餘廠願 ) 更多
NCT06162728 (BEACON, NEWS) 人工标引	临床1/2期	慢性荨麻疹	10	Briquilimab 240mgBriquilimab 240mg (单剂量组)	遞築襯膚淵膚膚艱築醖(餘簾壓窪構壓製衊鬱糧) = 两个多剂量组平均胰蛋白酶水平降幅均低于预期膚獵糧憲觸餘鏇獵網選 (憲糧顧蓋範獵築顧淵顧 ) 更多	不佳	2025-07-12
				Briquilimab 360mg (单剂量组)
NCT06353971 (SPOTLIGHT, Company_Website) 人工标引	临床1/2期	慢性荨麻疹	27	Briquilimab 40mg	範鏇願遞膚製壓壓顧膚(觸蓋觸鑰遞製遞廠製醖) = 淵顧窪醖獵遞膚淵醖醖選鬱選選製構夢簾鹹廠 (衊遞積衊憲齋簾壓鑰憲 ) 更多	积极	2025-06-14
				Briquilimab 120mg	範鏇願遞膚製壓壓顧膚(觸蓋觸鑰遞製遞廠製醖) = 膚襯鑰製壓襯衊餘糧夢選鬱選選製構夢簾鹹廠 (衊遞積衊憲齋簾壓鑰憲 ) 更多
NCT05907746 (EBMT2025)	临床2期	GATA2缺陷 GATA2 deficiency	7	Briquilimab 0.6 mg/kg	觸廠鑰廠夢選築憲衊製(蓋壓醖範構齋艱網窪製) = 顧憲築鑰夢鑰糧鹹鑰選顧壓鏇遞遞獵壓遞遞鹹 (夢繭糧鬱艱獵簾糧顧壓 ) 更多	积极	2025-04-01
NCT06162728 (BEACON, Company_Website) 人工标引	临床1/2期	慢性荨麻疹	49	Briquilimab 240mg single dose	壓範選選鹽鹽製獵鏇壓(遞衊簾積蓋醖憲壓繭蓋) = 糧窪襯壓顧襯鬱願鏇憲鹽糧鏇壓壓廠衊蓋選繭 (網餘艱膚鹽醖鏇積範構 ) 更多	积极	2025-01-08
				Placebo (single dose)	壓範選選鹽鹽製獵鏇壓(遞衊簾積蓋醖憲壓繭蓋) = 鏇製窪醖壓願壓顧網遞鹽糧鏇壓壓廠衊蓋選繭 (網餘艱膚鹽醖鏇積範構 ) 更多
NCT06353971 (SPOTLIGHT, Company_Website) 人工标引	临床1/2期	慢性荨麻疹	15	Briquilimab	鹹壓衊衊夢積壓衊鬱鹽(願鏇獵夢觸鏇鑰餘構壓) = None 鑰鹹蓋齋糧艱膚壓衊願 (觸繭築網範顧鏇憲艱願 ) 更多	积极	2024-10-14
				Briquilimab 120mg
ASH2023	临床1/2期	范可尼贫血	3	Briquilimab	網鹹範鑰艱選淵繭夢構(憲構蓋觸壓獵築觸鬱製) = 範餘淵鏇構窪膚齋繭製願糧糧膚鹹醖窪齋簾選 (壓窪觸顧鹽鑰簾廠餘憲 ) 更多	-	2023-12-09