[Translation] Supplementary study of the Phase I clinical study on multiple-dose tolerance and pharmacokinetics of HR1405-01 injection in healthy subjects

1）观察中国健康受试者对HR1405-01注射液多次静脉给药的耐受性，初步评价HR1405-01注射液的人体安全性，为后期开展的临床试验提供安全剂量范围。 2）评估HR1405-01注射液在健康人体内的多次静脉给药的药代动力学特征。

[Translation]

1) To observe the tolerance of Chinese healthy subjects to multiple intravenous administration of HR1405-01 injection, preliminarily evaluate the human safety of HR1405-01 injection, and provide a safe dose range for later clinical trials. 2) To evaluate the pharmacokinetic characteristics of HR1405-01 injection after multiple intravenous administration in healthy humans.

Start Date13 May 2024

Sponsor / Collaborator

Nanjing Heron Pharmaceutical Science & Technology Co., Ltd.

[+1]

CTR20231854 / RecruitingPhase 3

瑞加诺生注射液用于负荷超声心动图试验诊断冠心病的多中心、随机、自身对照、阳性药对照的Ⅲ期临床研究

[Translation] A multicenter, randomized, self-controlled, positive drug-controlled phase III clinical study of Reganosane injection for the diagnosis of coronary heart disease in stress echocardiography

1、主要目的：以冠状动脉造影为金标准，评价与腺苷注射液相比，瑞加诺生注射液作为超声心动图负荷药物对于冠心病的诊断效能。 2、次要目的：评价与腺苷注射液相比，瑞加诺生注射液作为超声心动图负荷药物的安全性。

[Translation]

1. Primary purpose: Using coronary angiography as the gold standard, evaluate the diagnostic efficacy of Reganosane injection as an echocardiographic stress drug for coronary heart disease compared with adenosine injection. 2. Secondary purpose: Evaluate the safety of Reganosane injection as an echocardiographic stress drug compared with adenosine injection.

Start Date22 Aug 2023

Sponsor / Collaborator

Nanjing Ruikewei Biomedical Co. Ltd.Startup

[+1]

CTR20230975 / CompletedNot Applicable

度骨化醇注射液治疗慢性肾脏病血液透析合并继发性甲状旁腺功能亢进症患者的有效性和安全性的开放、单臂、多中心临床研究

[Translation] An open, single-arm, multicenter clinical study on the efficacy and safety of doxorubicin injection in the treatment of chronic kidney disease patients with hemodialysis and secondary hyperparathyroidism

评价度骨化醇注射液治疗慢性肾脏病血液透析合并继发性甲状旁腺功能亢进症的患者的有效性和安全性。

[Translation]

To evaluate the efficacy and safety of doxorubicin injection in the treatment of chronic kidney disease patients undergoing hemodialysis and secondary hyperparathyroidism.

Start Date05 May 2023

Sponsor / Collaborator

Nanjing Heron Pharmaceutical Science & Technology Co., Ltd.

[+1]

100 Clinical Results associated with Nanjing Heron Pharmaceutical Science & Technology Co., Ltd.

0 Patents (Medical) associated with Nanjing Heron Pharmaceutical Science & Technology Co., Ltd.

Literatures (Medical) associated with Nanjing Heron Pharmaceutical Science & Technology Co., Ltd.

01 Feb 2023·Life Sciences

Exosomal LINC00355 promotes the malignant progression of gastric cancer through histone deacetylase HDAC3-mediated TP53INP1 transcriptional inhibition

Article

Author: Wang, Junbin ; Zhang, Yunan ; Wang, Xue Jun ; Qi, Junxia ; Yang, Fen ; Zheng, Beiyao ; Li, Juxue ; Sun, Yiming ; Chen, Jinfei ; Zhang, Wei ; Zhao, Wenjing ; Gu, Yazhou

AIMSExosomes are a subpopulation of extracellular vesicles (EV) derived from multivesicular body (MVB) that transmit various cellular molecular constituents, including long noncoding RNAs (lncRNAs), to promote intercellular communication. Our aim was to investigate the function and mechanism of exosomal LINC00355 in gastric cancer cells.MAIN METHODSExosomal levels of LINC00355 in GC patients and healthy controls were measured by RT-qPCR. The effects of exosomal LINC00355 on GC cell viability, proliferation, migration and invasion were evaluated by CCK8, colony formation, Transwell and wound healing assays. The expression levels of Ki67 in xenograft tumor tissues were confirmed by immunohistochemistry assay, and apoptosis was analyzed by TUNEL apoptosis assay. Western blotting was used to monitor protein expression. RNA immunoprecipitation and RNA pulldown were performed to detect the interaction between LINC00355 and HDAC3. Chromatin immunoprecipitation was used to assess the interaction of HDAC3 with the TP53INP1 promoter.KEY FINDINGSExosomal LINC00355 levels were higher in plasma from gastric cancer patients than in plasma from healthy volunteers. Exosomal LINC00355 promoted the proliferation, migration and invasion of gastric cancer cell lines. RNA sequence analysis demonstrated that LINC00355 knockdown downregulated histone deacetylase HDAC3 and upregulated TP53INP1. Mechanistic investigation indicated that exosomal LINC00355 interacted with HDAC3 to suppress TP53INP1 transcription, which promoted epithelial-mesenchymal transition (EMT).SIGNIFICANCEExosomal LINC00355 plays a pivotal role in regulating EMT to induce the malignant progression of GC. Exosomal LINC00355 could be a promising biomarker in the early diagnosis and prognosis of GC.

01 May 2022·European Journal of Medicinal ChemistryQ1 · MEDICINE

HR1405-01, a Safe intravenous NSAID with superior anti-inflammatory and analgesic activities in preclinical trials

Q1 · MEDICINE

Article

Author: Ye, Hai ; Chen, Xingran ; Mao, Di ; Zhang, Can ; Min, Tao ; Lv, Tian ; Ding, Boxiang

Combinational utilization of intravenous non-steroidal anti-inflammatory drugs (NSAIDs) with opium analgesic is an effective alternative modality for pain control after surgery. This regimen is known for reducing the risk of addiction induced by opium analgesic. However, current intravenous NSAIDs have solubility problems, limiting their clinical applications. Although loxoprofen exhibits strong anti-inflammatory and analgesic activities with relatively low ulcerogenicity, its relatively low bioavailability makes it not an ideal drug candidate for intravenous injection. We selected the bioactive metabolite (6) of loxoprofen as a candidate and developed a new intravenous NSAID, HR1405-01. This metabolite exhibited significantly stronger anti-inflammatory and analgesic activities than parecoxib sodium injection or ibuprofen injection. The excellent potency and solubility of HR1405-01 allowed the avoidance of utilization of cosolvent in the formulation, resulting in fewer side effects and a better safety profile. Therefore, HR1405-01 might be a promising candidate for the development of a new intravenous NSAID.

01 Dec 2020·Biotechnology LettersQ4 · ENGINEERING & TECHNOLOGY

Enzymatic hydroxylation of L-pipecolic acid by L-proline cis-4-hydroxylases and isomers separation

Q4 · ENGINEERING & TECHNOLOGY

Article

Author: Huang, Fujun ; Sha, Feng ; Wu, Hongli ; Wei, Ping ; Ye, Hai ; Lu, Fan ; Chen, Jiao ; Cao, Fei

OBJECTIVESEstablish a complete and efficient method for the preparation of cis-5-hydroxy-L-pipecolic acids (cis-5HPA), including biotransformation and isomers separation and purification.RESULTSFor non-heme Fe(II)/α-KG-dependent dioxygenases, α-ketoglutarate (α-KG) has great influence on the stability of Fe(II) ions, which is also the basic of the hydroxylation reaction to the substrate. L-pipecolic acids (L-Pip) was converted to cis-5HPA by whole-cell catalysis in water, which can reduce the loss of Fe(II) ions. 120 mM L-Pip can be transformed to 93% via cell and Fe(II) ions continuous supplementation under the reaction system optimization (the molar ratio of ascorbic acid/FeSO₄·7H₂O and α-KG/L-Pip were 8:1 and 1:1, respectively). After the catalytic reaction, the amino protection strategy was adopted to improve the resolution of isomer products on silica gel chromatography, and the amino protected cis-5HPA was obtained with a yield of 86.7%.CONCLUSIONSWe established a method which is promising to be used for cis-5HPA largescale preparation. It also provides a suitable reference for this type of enzyme-catalyzed reaction and the hydroxy pipecolic acid isomers separation.

100 Deals associated with Nanjing Heron Pharmaceutical Science & Technology Co., Ltd.

100 Translational Medicine associated with Nanjing Heron Pharmaceutical Science & Technology Co., Ltd.

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Pipeline

Pipeline Snapshot as of 07 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

IND Approval

Phase 1 Clinical

Phase 2 Clinical

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Regadenoson ( A2aR )	Heart Diseases More	Approved
HR1405-01	Severe pain More	Phase 2
HR-1801 ( COX )	Pain, Postoperative More	Phase 1
HR-2001	Fever More	IND Approval
HR-1902	Pain More	Preclinical

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