An Open-label, Blinded Phase II Study Investigating the Treatment of Acute Large Hemispheric Infarction by Transcranial Bone Marrow Injection of RK-4 Injection

An open-label, blinded phase II study investigating the treatment of acute large hemispheric infarction by transcranial bone marrow injection of RK-4 injection For subjects with acute large hemispheric infarction who are contraindicated to vascular recanalization or have poor response to vascular recanalization therapy, the safety, tolerability, and PK characteristics of RK-4 injection injected into the brain cell marrow through the cranial bone marrow will be preliminarily evaluated, and the efficacy will be preliminarily explored. The main questions it aims to answer are:
* The efficacy of RK-4 injection injected into the brain cell marrow through the cranial bone marrow.
* If drug RK-4 is safe and tolerate in the patients with LHI? Researchers will analyze data from different groups, includes cranial administration group and conventional treatment group , to see efficacy of RK-4 injection injected into the brain cell marrow through the cranial bone marrow and If drug RK-4 is safe and tolerate in the patients with LHI .
Participants will:
* Take drug RK-4 (2mg/mL, 1mL) by transcranial bone marrow injection once daily for consecutive 3 days or just receive conventional treatments.
* Truthfully provide medical history and "previous participation in clinical trials" and a statement of no history of mental disorders.
* Take the drug at the specified time every day according to the dosage prescribed by the doctor
* Receive the investigational drug as instructed by the doctor and visiting as required
* Tell the investigators about any medications (including chemicals, biological drugs, proprietary Chinese medicines, etc.) and related treatments you take during the study
* unpermitted stop the investigational drug yourself at the end of the study or when you decide to withdraw from the study, you need to stop the investigational drug as directed by your doctor to ensure your safety
* take reasonable contraception actions
* unallowed to use unmarketed drugs or other clinical trial drugs during the study

开始日期2025-11-01

申办/合作机构

福州宁丹榕康生物医药科技有限公司

ChiCTR2500111296

/ Not yet recruiting临床2期IIT

A Study on the Efficacy and Safety of Treating Acute Large Hemispheric Infarction by Injecting RK-4 Injection through the Skull Bone Marrow — A Multicenter, Prospective, Randomized, Open-label, Blinded-endpoint Clinical Study

开始日期2025-10-10

申办/合作机构-

ChiCTR2500110119

/ Not yet recruiting临床1/2期IIT

A single-arm, open-label, blind-endpoint Ib/IIa study investigating the treatment of acute large cerebral hemisphere infarction with RK-4 injection through cranial bone marrow

开始日期2025-09-30

申办/合作机构-

100 项与 RK-4 相关的临床结果

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100 项与 RK-4 相关的转化医学

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100 项与 RK-4 相关的专利（医药）

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项与 RK-4 相关的文献（医药）

2025-10-01·Royal Society Open Science

Exploring the potential of biphenylamine- and triphenylamine-based sensitizers for enhanced efficiency of more than 8% in dye-sensitized solar cells

Article

As the world’s population and industrial sector rapidly expand, the demand for energy is rising. Solar cells can address both global energy and environmental needs. With the aim to enhance dye-sensitized solar cell (DSSC) efficiency, we designed four metal-free biphenylamine- and triphenylamine-based dyes (RK2–RK5) based on the reference dye RK1, increasing the donor strength (substituting different groups such as biphenylamine and triphenylamine into the donor side of the dye) as such dyes improved DSSC power conversion efficiency. Density functional theory (DFT) was applied at the B3LYP/6–31G** level to calculate the ground-state (S 0 ) optimized geometries of RK1-RK5. Time-dependent DFT was used to compute the absorption spectra, utilizing four functionals (B3LYP, CAM-B3LYP, PBE1PBE and BHandHLYP), in the gas phase and in solvents such as dichloromethane and ethanol. Comprehensive analysis of RK1-RK5 as well as dyes@TiO 2 was performed, and light was shed on the optoelectronic properties. Frontier molecular orbitals' charge density distribution revealed the sensitizers' intramolecular charge transfer from the donor to the acceptor unit. After adsorption of the dyes on TiO 2 , charge transfer was seen from sensitizer to the TiO 2 semiconductor’s surface in dyes@TiO 2 . Adsorption of the dyes on the TiO 2 cluster would be stable, as revealed by the dyes@TiO 2 cluster’s negative binding energy. Additionally, it was found that the presence of two donor groups raises the electronic coupling and electron injection constants in RK4 and RK5, indicating that the charge injection in these newly designed dyes would be superior. As a result, the DSSC efficiency in the newly designed derivatives has been improved to 8.05% for RK5 by substituting the triphenylamine unit at the R1 and R2 positions in the parent compound. These well established correlations between structure–property relationships and performance provide profound insight into how improving the donor moiety strength in organic sensitizers affects device performance. It boosted photovoltaic performance through enhanced short-circuit current density and light-harvesting efficiency. For high efficiency in DSSCs, this can provide a useful rational molecular design strategy for D–π–A organic sensitizers.

1990-11-01·Immunobiology4区 · 医学

A Monoclonal Antibody Recognizing Selectively Rat Granulocytes

4区 · 医学

Article

作者: Friedhelm Steinhausen ; J. Hinrich Peters ; Rita Kuhn ; Hermann Josef Gröne ; Hui Xu

In the present study, a murine monoclonal antibody, RK-4 (IgG1) specific for rat granulocytes and their precursors in blood and bone marrow is described. Results obtained by immunocytological and flowcytometry analysis showed this mAb to recognize selectively a surface antigen on neutrophils, eosinophils and basophils. Analysis of cryosections of various lymphatic and non-lymphatic organs demonstrates that this mouse antibody does not cross-react with any other structures. By flow cytometric analysis we found peripheral blood leukocytes to consist of about 15-20% granulocytes. RK-4 is therefore a valuable tool for studying differentiation and function of granulocytes under various conditions.

项与 RK-4 相关的新闻（医药）

2025-08-22

·同写意

化药1类RK-4注射液IND获国家药监局批准丨会员动态

临床申请申请上市

2025-08-01

·宁丹新药

宁丹榕康|化药1类RK-4注射液IND获国家药监局批准

点击蓝字关注我们2025年07月25日，宁丹新药全资子公司福州宁丹榕康生物医药科技有限公司（简称“宁丹榕康”）化药1类RK-4注射液获得国家药监局颁发的药物临床试验批准通知书（2025LP01893）。RK-4注射液是由宁丹榕康生物医药科技有限公司开发，具有独立知识产权的全球首个通过颅骨骨髓腔注射治疗急性大脑半球大面积梗死新药品种。大脑半球大面积梗死（large hemispheric infarction, LHI）是涉及前循环区域二分之一到三分之二的梗塞，伴或不伴大脑前动脉/大脑后动脉供血区域梗死，约占缺血性脑卒中的10%。即使经过积极的内科治疗，其病死率仍高达60%~80%；约2/3的生存患者遗留严重残疾。因此该现状提示，目前LHI缺乏有效治疗手段，给社会造成沉重负担，具有重大临床需求。RK-4注射液经颅骨骨髓腔注射后，药物能快速进入脑实质，并以有效浓度分布到病灶部位，为LHI患者提供了全新的治疗手段。宁丹榕康拟于近期启动临床研究。撰稿|华垚编辑|朱雯封面|沙蕊审核|陈荣余鹏关于宁丹宁丹新药是一家聚焦于中枢神经系统疾病（CNS）领域新药研发和产业化的创新型公司，拥有全流程、全链条的新药研发平台和自主研发能力，国家级高新技术企业、长三角创新研发型企业、江苏省专精特新中小企业。公司项目管线主要用于卒中、颅内肿瘤、认知障碍、情感障碍、神经病理性疼痛、脑小血管病等多个高发中枢相关疾病，目前分别处于临床中和临床前研究阶段。更多信息请访问：https://www.neurodawn.cn关于宁丹榕康福州宁丹榕康生物医药科技有限公司，成立于2025年，是宁丹新药技术股份有限公司持股的全资子公司，企业注册资本5000万人民币。公司立足福州新区生物医药创新高地，致力于新型药物研发递送技术和核酸药物的开发。

临床申请

100 项与 RK-4 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
脑梗塞	临床2期	中国	福州宁丹榕康生物医药科技有限公司	2025-10-11
急性缺血性卒中	临床2期	中国	南京宁丹新药技术股份有限公司	2025-09-20
梗塞	临床2期	中国	南京宁丹新药技术股份有限公司	2025-09-20