A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of HH-120 Nasal Spray for Post-exposure Prophylaxis of SARS-CoV-2

This study will assess the efficacy of HH-120 nasal spray in participants for the post-exposure prevention of SARS-CoV-2.

开始日期2023-03-31

申办/合作机构

华辉安健（北京）生物科技有限公司

NCT05713318 / Completed临床2期

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of HH-120 Nasal Spray for the Treatment of Mild COVID-19

This is a randomized, double-blind, placebo-controlled Phase 2 study in participants over the age of 18 years with mild COVID-19. The main purpose of this study is to evaluate the effect on viral load clearance and clinical recovery, and safety of HH-120 nasal spray in participants over the age of 18 years with mild COVID-19 (according to the FDA definition, 2021).

开始日期2023-01-18

申办/合作机构

华辉安健（北京）生物科技有限公司

NCT05753878 / Completed临床1期

A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic and Immunogenicity of HH-120 Nasal Spray in Healthy Subjects

This is a clinical study evaluating the safety, tolerability, pharmacokinetic (PK) characteristics and immunogenicity of HH-120 nasal spray in healthy subjects. This study is divided into two parts: Part A is of open-label design and mainly aims to assess the local distribution and PK in nasal cavity of HH-120 nasal spray, subjects from 10 cohorts are sequentially enrolled to perform either nasal endoscopic examination or nasal/ nasopharyngeal samples collection at different time points post administration. Part B mainly aims to assess the safety, systematic pharmacokinetic and immunogenicity after multiple dosing of HH-120 nasal spray, subjects are randomly assigned (3:1) to HH-120 and placebo groups.

开始日期2022-11-08

申办/合作机构

华辉安健（北京）生物科技有限公司

100 项与 HH-120 相关的临床结果

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100 项与 HH-120 相关的转化医学

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100 项与 HH-120 相关的专利（医药）

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项与 HH-120 相关的文献（医药）

2023-12-01·Journal of Medical Virology

Nasal spray of an IgM‐like ACE2 fusion protein HH‐120 prevents SARS‐CoV‐2 infection: Two investigator‐initiated postexposure prophylaxis trials

Article

作者: Li, Guangyu ; Lei, Cong ; Sui, Jianhua ; Zou, Liangfeng ; Chen, Xiaoyou ; Zhou, Yunao ; Liu, Zhe ; Guo, Xiaodi ; Li, Baoliang ; Ni, Jun ; Song, Rui ; Li, Wenhui ; Jin, Ronghua ; Liang, Xiao ; Liu, Juan ; Mao, Fengfeng ; Zhang, Hongbin ; Yang, Fang

AbstractHH‐120, an IgM‐like angiotensin converting enzyme 2 (ACE2) fusion protein, has been developed as a nasal spray against Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) and is currently undergoing human trials. HH‐120 nasal spray was assessed for postexposure prophylaxis (PEP) in two investigator‐initiated (NS01 and NS02) trials with different risk levels of SARS‐CoV‐2 exposure. NS01 enrolled family caregiver participants who had continuous contacts with laboratory‐confirmed index cases; NS02 enrolled participants who had general contacts (Part 1) or close contacts (Part 2) with index cases. The primary endpoints were safety and laboratory‐confirmed and/or symptomatic SARS‐CoV‐2 infection. In NS01 trial (14 participants), the SARS‐CoV‐2 infection rates were 25% in the HH‐120 group and 83.3% in the external control group (relative risk reduction [RRR]: 70.0%). In NS02‐Part 1 (193 participants), the infection rates were 4% (HH‐120) versus 11.3% (placebo), symptomatic infection rates were 0.8% versus 3.5%, hence with a RRR of 64.6% and 77.1%, respectively. In Part 2 (76 participants), the infection rates were 17.1% (HH‐120) versus 30.4% (placebo), symptomatic infection rates were 7.5% versus 27.3%, with a RRR of 43.8% and 72.5%, respectively. No HH‐120‐related serious adverse effects were observed. The HH‐120 nasal spray used as PEP was safe and effective in preventing laboratory‐confirmed and symptomatic SARS‐CoV‐2 infection.

2023-05-01·Journal of Medical Virology

Nasal spray of an IgM‐like ACE2 fusion protein HH‐120 accelerates SARS‐CoV‐2 clearance: A single‐center propensity score‐matched cohort study

Article

作者: Sui, Jianhua ; Song, Rui ; Guo, Xiaodi ; Li, Wenhui ; Mao, Fengfeng ; Liu, Zhe ; Liang, Xiao ; Zhang, Hongbin ; Jin, Ronghua ; Chen, Xiaoyou ; Zou, Liangfeng ; Li, Baoliang ; Lei, Cong

AbstractHH‐120, a recently developed IgM‐like ACE2 fusion protein with broad‐spectrum neutralizing activity against all ACE2‐utilizing coronaviruses, has been developed as a nasal spray for use as an early treatment agent to reduce disease progression and airborne transmission. The objective of this study was to evaluate the safety and efficacy of the HH‐120 nasal spray in SARS‐CoV‐2‐infected subjects. Eligible symptomatic or asymptomatic SARS‐CoV‐2‐infected participants were enrolled in a single‐arm trial to receive the HH‐120 nasal spray for no longer than 6 days or until viral clearance at a single hospital between August 3 and October 7, 2022. An external control was built from real‐world data of SARS‐CoV‐2‐infected subjects contemporaneously hospitalized in the same hospital using a propensity score matching (PSM) method. After PSM, 65 participants in the HH‐120 group and 103 subjects with comparable baseline characteristics in the external control group were identified. The viral clearance time was significantly shorter in participants receiving the HH‐120 nasal spray than that in subjects of the control group (median 8 days vs. 10 days, p < 0.001); the difference was more prominent in those subgroup subjects with higher baseline viral load (median 7.5 days vs. 10.5 days, p < 0.001). The incidence of treatment‐emergent adverse events and treatment‐related adverse events of HH‐120 group were 35.1% (27/77) and 3.9% (3/77), respectively. All the adverse events observed were mild, being of CTCAE grade 1 or 2, and transient. The HH‐120 nasal spray showed a favorable safety profile and promising antiviral efficacy in SARS‐CoV‐2‐infected subjects. The results from this study warrant further assessment of the efficacy and safety of the HH‐120 nasal spray in large‐scale randomized controlled clinical trials.

Nature Communications1区 · 综合性期刊

An IgM-like inhalable ACE2 fusion protein broadly neutralizes SARS-CoV-2 variants

1区 · 综合性期刊

ArticleOA

作者: Li, Guangyu ; Hao, Dongxia ; Yao, Yuansheng ; Liu, Juan ; Liu, Zibing ; Choe, Hyeryun ; Huang, Baoying ; Tian, Xinxin ; Lin, Yongqing ; Chen, Pan ; Liu, Ximing ; Yuen, Kwok-Yung ; Liu, Chunmei ; Yang, Fang ; Peng, Xiaozhong ; Mao, Fengfeng ; Qi, Yonghe ; Peng, Ran ; Sheng, Yao ; Farzan, Michael ; Liu, Haimo ; Tan, Wenjie ; Lu, Shuaiyao ; Jin, Ronghua ; Huang, Panpan ; Li, Xue ; Song, Rui ; Zheng, Yule ; Yu, Guimei ; Sun, Yinyan ; Fang, Linqiang ; Sa, Rigai ; Li, Wenhui ; Sui, Jianhua ; Luo, Junmian ; Ding, Yu ; Chen, Jianhe ; Yeung, Man Lung ; Cheng, Yurui

AbstractMany of the currently available COVID-19 vaccines and therapeutics are not effective against newly emerged SARS-CoV-2 variants. Here, we developed the metallo-enzyme domain of angiotensin converting enzyme 2 (ACE2)—the cellular receptor of SARS-CoV-2—into an IgM-like inhalable molecule (HH-120). HH-120 binds to the SARS-CoV-2 Spike (S) protein with high avidity and confers potent and broad-spectrum neutralization activity against all known SARS-CoV-2 variants of concern. HH-120 was developed as an inhaled formulation that achieves appropriate aerodynamic properties for rodent and monkey respiratory system delivery, and we found that early administration of HH-120 by aerosol inhalation significantly reduced viral loads and lung pathology scores in male golden Syrian hamsters infected by the SARS-CoV-2 ancestral strain (GDPCC-nCoV27) and the Delta variant. Our study presents a meaningful advancement in the inhalation delivery of large biologics like HH-120 (molecular weight (MW) ~ 1000 kDa) and demonstrates that HH-120 can serve as an efficacious, safe, and convenient agent against SARS-CoV-2 variants. Finally, given the known role of ACE2 in viral reception, it is conceivable that HH-120 has the potential to be efficacious against additional emergent coronaviruses.

项与 HH-120 相关的新闻（医药）

2024-04-05

·药融圈

顶级PI创立，战略切入布局ADC的Biotech

▲5月30-31日第八届广州生物医药创新者峰会扫码立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。药融云数据（www.pharnexcloud.com）监测显示：近期，华辉安健（北京）生物科技有限公司（“华辉安健”）宣布将在2024年4月5日至10日举行的美国癌症研究协会年会（AACR 2024）上展示其与普方生物共同开发的HH018-sesutecan的临床前研究结果。本品由华辉安健主导开发。药融云数据，www.pharnexcloud.com，专利数据HH018-sesutecan是一款 “first-in-class”候选抗体偶联药物（ADC），以华辉安健的抗-CD98单克隆抗体HH018为基础，并结合普方生物的sesutecan ADC平台开发的泛瘤种ADC，有望实现对多种肿瘤的高效且精准的抗肿瘤活性。HH-018单抗通过酸性pH依赖性地结合CD98，从而选择性地靶向酸性肿瘤微环境，不仅提升药物靶向肿瘤的特异性和安全性，而且具有良好的体内药代动力学特征。HH018-sesutecan能够通过内吞作用进入肿瘤细胞内，对肿瘤细胞具有强细胞毒性。在多种小鼠肿瘤模型中，如结直肠癌、头颈鳞癌、黑色素瘤、卵巢癌、淋巴瘤等，HH018-sesutecan表现出剂量依赖性的抗肿瘤活性。在食蟹猴体内进行的预毒理研究中，HH018-sesutecan显示了良好的药代动力学特征，在30mg/kg给药剂量下安全性良好。其中抗体相关专利为WO2022252167A1。Huahui Pipeline华辉安健是一家在2015年1月创立于中国北京，专注于病毒学、肝病学和相关肿瘤学领域创新药物研发的临床阶段生物科技公司。公司聚焦抗病毒（如乙肝、丁肝）和相关肿瘤学领域，具备从药物发现、临床前开发、转化科学研究、临床开发到生产与注册的“端到端（end-to-end）” 能力和完整体系。公司多款具有潜在“First-in-Class”或者“Best-in-Class”的在研药物处于临床开发阶段，包括有望实现慢性乙肝功能性治愈的单抗药物HH-003和HH-006、广谱抗新冠病毒融合蛋白HH-120、免疫肿瘤抗体HH-101、抗肿瘤靶向药HH-009等。公司由李文辉博士创立，联合创始人有隋建华博士；首席执行官/CEO陈彬博士、CSO叶斌博士（临床及科学转化）。1.HH-120是基于人ACE2的类IgM样重组融合蛋白，可以全谱高效中和所有通过ACE2受体介导的新冠病毒（包括XBB，BA2.86, 和JN.1等突变株）。HH-120药物不进入血液、无系统暴露风险。HH-120自2020年初新冠疫情开始研发。2023年12月，在《JOURNAL OF MEDICAL VIROLOGY》发表了题为“Nasal spray of an IgM‐like ACE2 fusion protein HH‐120 prevents SARS‐CoV‐2 infection: Two investigator‐initiated postexposure prophylaxis trials”的研究成果。doi/10.1002/jmv.292752.2023年4月25日，华辉安健宣布其自主研发的创新药物HH-003注射液近日被国家药品监督管理局（NMPA）/药品审评中心（CDE）纳入突破性治疗品种（BTD），用于治疗慢性丁型肝炎病毒感染。本品为全球首个靶向乙肝病毒表面大包膜蛋白前S1（PreS1）区的乙肝病毒中和抗体。3.2023年2月9日，华辉安健与广州誉衡生物科技有限公司（以下简称“誉衡生物”）共同宣布建立临床研究合作伙伴关系。双方就华辉安健的抗TIGIT单克隆抗体HH-101注射液和誉衡生物的抗PD-1单克隆抗体赛帕利单抗注射液（商品名：誉妥®）展开联合治疗临床研究，旨在评估该联合用药在多种实体肿瘤患者中的有效性和安全性。新药并购案子又来了ADC新锐普方生物pipeline（包括rinatabart sesutecan (Rina-S; PRO1184)，一种靶向FRα的ADC；PRO1160，一种靶向CD70的ADC；PRO1107，一种靶向PTK7的ADC；以及PRO1286，一种靶向EGFR和cMET的双特异性ADC）。第一单！18亿美元，中国ADC企业被巨头并购。2024年4月3日，总部在丹麦哥本哈根的 Genmab A/S (纳斯达克代码:GMAB) 和普方生物（ProfoundBio, Inc.）宣布，两家公司已达成最终协议，Genmab将通过全现金交易收购普方生物。Genmab对普方生物的收购对价为18亿美元，在交易完成时将以现金支付。（目前198亿美元市值，关联阅读：从“垂死挣扎”到“起死回生”，Genmab如何吸引大厂争相合作）。参考：NMPA/CDE；药融云数据，www.pharnexcloud.com；FDA/EMA/PMDA；相关公司公开披露；www.huahuihealth.com；https://pharma.bcpmdata.com/database/1/detail/48/_jomf44BfFW7AIEH5Gmb；https://profoundbio.com/；https://onlinelibrary.wiley.com/doi/10.1002/jmv.29275；https://www.huahuihealth.com/html/pressrelease/49.html；2022年会（AASLD 2022）公布HH-003首次在慢性乙肝病毒（HBV）感染者中的Ib期临床试验数据；等等。本文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐活动推荐 8月 • NDC2024生物医药创新博览会关键词：抗体、多肽、核酸、核药，XDC、小分子、注册、临床、CMC（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

抗体药物偶联物AACR会议引进/卖出CSCO会议

2024-04-04

·PRNewswire

Huahui Health to Present Preclinical Data of HH018-sesutecan at the 2024 AACR Annual Meeting

BEIJING, April 4, 2024 /PRNewswire/ -- Huahui Health Ltd.("Huahui Health"), a clinical stage biotechnology company focused on discovering and developing virology, hepatology, and oncology therapies, announced that it will present the results of preclinical data of HH018-sesutecan, a tumor microenvironment targeting CD98-directed ADC, at the American Association for Cancer Research (AACR) Annual Meeting 2024. The AACR meeting will be held April 5–10, 2024, in San Diego, California. Topic: A tumor microenvironment-targeting CD98-directed ADC confers robust anti-tumor activity in multiple cancers with favorable pharmacokinetics and safety profiles in preclinical models Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 4 Session Date and Time: Wednesday Apr 10, 2024 9:00 AM - 12:30 PM Location: Poster Section 54 Poster Board Number: 1 Abstract Presentation Number: LB425 Presenter: Bin Chen, CEO of Huahui Health. Zhu Chen, CSO of ProfoundBio About Huahui Health Huahui Health is a clinical-stage biotechnology company founded in 2015 in Beijing, China. With a focus on virology, hepatology, and oncology, the company is dedicated to drug discovery, development, and antibody engineering. It has expanded its pipeline to include promising drug candidates in virology and oncology, aiming to launch multiple groundbreaking products and lead the way in antiviral and oncology research. Two leading programs have entered the pivotal clinical trial stage. One is HH-003, the first anti-preS1 HBV/HDV neutralizing antibody to enter a pivotal study for chronic HDV infection. The other is HH-120, an IgM-like ACE2-Fc recombinant fusion protein via nasal spray, currently undergoing a phase 3 trial for post-exposure prophylaxis of SARS-CoV-2. For more information, please visit . SOURCE Huahui Health Ltd.

临床3期AACR会议

2023-04-05

·医药笔记

洛启生物：抗体吸入给药的系统性机会

▎Armstrong2022年全球畅销药TOP20中，有8款是大分子药物，剔除新冠相关则比例会更高，最畅销的两款药物Humira、Keytruda都是抗体药物。从1986年首款开始，FDA累计批准了120款抗体药物，2022年市场规模达到2200亿美元。这已经上市的120款抗体药无一例外的都是通过注射给药，包括静脉注射、皮下注射、玻璃体注射等方式。对于一些慢病来说，给药路径的优化显得尤为重要，这也成为药物迭代的重要方向之一。如VEGF抗体或融合蛋白治疗眼病，需要复杂的玻璃体注射，因此延长给药周期就成为竞争焦点，从每个月一针到现在的4个月一针，已经取得巨大进步。再如辉瑞116亿美元收购Biohaven，获得CGRP小分子抑制剂。众多公司开发GLP-1R小分子、PCSK9口服小分子或环肽抑制剂、PD-L1小分子抑制剂等，都是希望以口服给药来替代注射给药。事实上，大分子药物本身的给药路径创新也一直在积极推进当中。洛启生物、阿斯利康、再鼎医药等公司已经在抗体药吸入给药或皮肤给药方面取得了阶段性进展。再鼎医药作为IL-17靶点的后来者，开发了单域抗体，通过外用给药，被证明可以实现透皮肤的效果，对轻至中度银屑病取得很好的初步临床数据。新冠疫情中，一些蛋白疫苗、重组蛋白预防药物也陆续实现了鼻喷或雾化吸入给药，通过粘膜免疫或竞争性结合来预防感染。如华辉安健的HH-120为一款ACE2-IgM-Fc融合蛋白，通过雾化吸入给药，达到暴露后预防的效果，目前已经启动三期临床。阿斯利康从Pieris引进的AZD1402为一款类抗体anticalin分子，靶向IL-4R通路，通过吸入给药治疗哮喘，目前处于二期临床阶段。洛启生物成立于2017年，是呼吸系统疾病吸入给药抗体药物研发的龙头公司之一，其IL-4R纳米抗体LQ036、TSLP纳米抗体LQ043即采用吸入给药，目前处于临床一期研究阶段。对于呼吸系统疾病，吸入给药完美结合了纳米抗体的优势。以IL-4R纳米抗体LQ036为例，主要用于治疗中重度哮喘，吸入给药可以直达病理部位，起效更快（2天起效，抗体一般是4周起效），给药量低，仅为Dupixent的3%（Dupixent为300mg，LQ036为10mg）。由于进入血液系统的药物比例很低（1%），系统副作用很低。此外，作为纳米抗体，LQ036可以采用毕赤酵母来生产，生产成本远低于动物细胞表达，并且生产工艺更易放大，非常适合慢性病长用药周期、用量大的需求。LQ043为全球首款广谱哮喘/COPD吸入式TSLP纳米抗体治疗药物，与LQ036一样，吸入给药起效更快，并可以减少用量，增加安全性。LQ043采用毕赤酵母系统生产，产量高达20g/L，生产成本远低于动物细胞表达的抗体药物，有望具备小分子药物的价格优势并实现抗体药物的疗效及安全性。洛启生物的研发管线中，还包括治疗肺纤维化的LQ056和治疗囊性纤维化的LQ059，同样采用吸入给药。总结近年来，抗体药物的给药路径创新取得了很多进展，尤其是中国药企做了很多原创性的探索工作。皮肤病、呼吸系统疾病等比较适合开发新的大分子给药路径，单域抗体或纳米抗体则因其分子量小、稳定性强的特点非常适合用于这类场景。洛启生物围绕纳米抗体吸入给药治疗呼吸系统疾病进行了广泛布局，有望抓住呼吸系统疾病重磅抗体药物迭代开发的系统性机会。相信这一类的抗体药给药路径创新，将成为差异化设计迭代药物的一个个里程碑，期待这些产品的后续临床进展。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

临床2期并购疫苗临床3期

100 项与 HH-120 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
新型冠状病毒感染	临床3期	中国	华辉安健（北京）生物科技有限公司	2023-03-31
COVID-19 呼吸道感染	药物发现	澳大利亚	华辉安健（北京）生物科技有限公司	2021-11-01