BUENOS AIRES, Argentina, April 15, 2024 /PRNewswire/ -- LongBio Pharma (Suzhou) Co., Ltd. (referred to as 'LongBio'), a leading biotech company dedicated to developing innovative protein treatments for nephrology, allergy, respiratory, hematology, ophthalmology, and other autoimmune and rare diseases, proudly announced the release of pre-clinical data of LP-005, a novel bi-functional complement antibody-fusion protein, at the 2024 World Congress of Nephrology (WCN24) held by International Society of Nephrology (ISN)..

阿根廷布宜诺斯艾利斯，2024年4月15日/PRNewswire/--LongBio Pharma（Suzhou）Co.，Ltd.（简称“LongBio”），一家领先的生物技术公司，致力于开发用于肾脏病，过敏，呼吸，血液学，眼科和其他自身免疫和罕见疾病的创新蛋白质治疗方法，在国际肾脏病学会（ISN）举办的2024年世界肾脏病大会（WCN24）上，骄傲地宣布发布新型双功能补体抗体融合蛋白LP-005的临床前数据。。

The poster titled 'Bi-functional C5 antibody-fusion protein (LP-005) with potential best-in-class bioactivity for complement inhibition' was presented by LongBio during the conference.

LongBio在会议期间发布了题为“具有补体抑制潜在最佳生物活性的双功能C5抗体融合蛋白（LP-005）”的海报。

Date and Time: April 15, 2024, at 17:45 pm (UTC -3)

日期和时间：2024年4月15日下午17:45（UTC-3）

Location: Exhibition Hall and Main Foyer

地点：展厅和主门厅

Poster Number: MON-100

海报编号：MON-100

Methods: Eculizumab, POT-4 (also known as APL-1) was purchased from vendors. The sequences of Ravulizumab, Crovalimab, Pozelimab, Narsoplimab and Ab-fH were obtained from INN and made in-house with LP-005, LP-005C. CP, AP, LP and C3b deposition assays with head-to-head comparison were conducted. Monkey PK/PD assay of LP-005C and Ab-fH was also conducted..

方法：依库利珠单抗POT-4（也称为APL-1）购自供应商。Ravulizumab，Crovalimab，Pozelimab，Narsoplimab和Ab fH的序列获自INN，并用LP-005，LP-005C内部制备。进行了CP，AP，LP和C3b沉积测定，并进行了头对头比较。还进行了LP-005C和Ab fH的猴PK/PD测定。。

Results: LP-005 shows the most potent inhibition in CP, AP and LP compared to Eculizumab, Ravulizumab, Crovalimab, Pozelimab and Narsoplimab.In addition, it also has the most efficient inhibition in C3b assay compared to Antibody-fH fusion and POT-4 (APL-1).The monkey PK/PD study indicates that when fusing to the same C5 antibody, LongBio's unique inhibitor (inCibitorTM) shows a better PK/PD profile compared to the natural fH 1-5 fragment..

结果：与依库利珠单抗，Ravulizumab，Crovalimab，Pozelimab和Narsoplimab相比，LP-005在CP，AP和LP中显示出最有效的抑制作用。此外，与抗体fH融合和POT-4（APL-1）相比，它在C3b测定中也具有最有效的抑制作用。猴子PK/PD研究表明，与天然fH 1-5片段相比，当与相同的C5抗体融合时，LongBio的独特抑制剂（inCibitorTM）显示出更好的PK/PD谱。。

LP-005 is a novel bifunctional complement antibody fusion protein targeting both C3 and C5, with better bioactivity in CP, AP, LP and C3b deposition assays. Meanwhile, LP-005 is engineered to optimize surface charge (PI) and FcRn binding, making it first Q4W bi-functional complement inhibitor all over the world.

LP-005是一种靶向C3和C5的新型双功能补体抗体融合蛋白，在CP，AP，LP和C3b沉积测定中具有更好的生物活性。同时，LP-005被设计用于优化表面电荷（PI）和FcRn结合，使其成为全球首个Q4W双功能补体抑制剂。

With all these advantages above, LP-005 has the potential to be a best-in-class drug candidate with excellent and full complement inhibitory activity and will be explored in complement mediated disorders..

凭借上述所有优势，LP-005有可能成为具有优异且完全补体抑制活性的同类最佳候选药物，并将在补体介导的疾病中进行探索。。

LP-005's phase I study in healthy volunteers will be completed in 2024Q2 in China. At present, LP-005 showed expected PK/PD profile and well tolerated safety profile. More clinical data will be unveiled at 2024 European Meeting on Complement in Human Diseases in September. The phase II studies with indication of IgAN (IgA Nephropathy) and PNH (Paroxysmal nocturnal hemoglobinuria, rare disease) will initial in 2024Q2.

LP-005的健康志愿者第一阶段研究将于2024Q2在中国完成。目前，LP-005显示出预期的PK/PD特征和良好的耐受性安全性。更多的临床数据将在9月举行的2024年欧洲人类疾病补体会议上公布。具有IgAN（IgA肾病）和PNH（阵发性夜间血红蛋白尿，罕见疾病）指征的II期研究将于2024Q2开始。

Other indications in neurology and ophthalmology are also scheduled to develop..

神经病学和眼科的其他适应症也计划开发。。

About InCibitor™

关于InCibitor™

InCibitorTM is a new generation of complement inhibitor platform developed by LongBio. The bi-functional complement inhibitor LP-005 developed based on this platform is going to start Phase II study of IgAN and PNH. LongBio is also exploring the development of new drugs related to hematology, nephrology, neurology, ophthalmology, oncology, and gene therapy based on this platform..

InCibitorTM是LongBio开发的新一代补体抑制剂平台。基于该平台开发的双功能补体抑制剂LP-005将开始IgAN和PNH的II期研究。LongBio还在探索基于该平台开发与血液学、肾脏学、神经病学、眼科、肿瘤学和基因治疗相关的新药。。

About LongBio

关于LongBio

LongBio Pharma is a biotech company located in Shanghai/Changshu, China. The company, which was founded in 2018, focuses on autoimmune and rare diseases, serving patients and society.

LongBio Pharma是一家位于中国上海/常熟的生物技术公司。该公司成立于2018年，专注于自身免疫和罕见疾病，为患者和社会服务。

LongBio Pharma aims to bring our drugs to both domestic and international markets with our partners, especially to bring patients with more affordable and high-quality bio-medicines. Our leading pipeline is a next generation of anti-IgE antibody (LP-003), which is about to start Phase III study in 2024Q2, and prepare for BLA in 2025H1.

LongBio Pharma的目标是与我们的合作伙伴一起将我们的药物推向国内和国际市场，特别是为患者提供更实惠和高质量的生物药物。我们的主要管道是下一代抗IgE抗体（LP-003），该抗体将于2024Q2开始III期研究，并于2025H1准备BLA。

The second leading pipeline is a bi-functional complement antibody fusion-protein (LP-005) , which is in Phase I at present, intending to start Phase II/III in 2024Q2..

第二个主要管道是双功能补体抗体融合蛋白（LP-005），目前处于I期，计划在2024Q2开始II/III期。。

For more information, please visit: www.longbio.com or please contact: bd@longbio.com.

有关更多信息，请访问：www.longbio.com或联系：bd@longbio.com.

SOURCE LongBio

来源：Longbio