（1）通过初步剂量持续时间-效应的探索研究测定丙酸氟替卡松乳膏参比制剂（规格：0.05%；持证商：Padagis Israel Pharmaceuticals Ltd）在中国健康受试者中的剂量持续时间-效应关系，确定后续体内生物等效性试验中的剂量持续时间（ED50）和预期满足AUEC值的D2/D1最小比值的受试者比例；（2）结合初步剂量持续时间-效应探索研究结果，设计合适的研究条件，以湖北生物医药产业技术研究院有限公司提供的丙酸氟替卡松乳膏（规格：0.05%）为受试制剂，以Padagis Israel Pharmaceuticals Ltd持证的丙酸氟替卡松乳膏（规格：0.05%）为参比制剂进行人体生物等效性试验，通过比较两制剂的药效学参数，评价两制剂的生物等效性。（3）以湖北生物医药产业技术研究院有限公司提供的丙酸氟替卡松乳膏（规格：0.05%）为受试制剂，以Padagis Israel Pharmaceuticals Ltd持证的丙酸氟替卡松乳膏（规格：0.05%）为参比制剂，研究局部给药后受试制剂与参比制剂的体内暴露量比，从而评价受试制剂的安全性。

[Translation]

(1) The dose-duration-effect relationship of the reference preparation of fluticasone propionate cream (specification: 0.05%; licensee: Padagis Israel Pharmaceuticals Ltd) in healthy Chinese subjects was determined through a preliminary dose-duration-effect exploratory study, and the dose-duration (ED50) and the proportion of subjects expected to meet the minimum D2/D1 ratio of the AUEC value in the subsequent in vivo bioequivalence test were determined; (2) Based on the results of the preliminary dose-duration-effect exploratory study, appropriate research conditions were designed, and the fluticasone propionate cream (specification: 0.05%) provided by Hubei Biomedical Industry Technology Research Institute Co., Ltd. was used as the test preparation, and the fluticasone propionate cream (specification: 0.05%) licensed by Padagis Israel Pharmaceuticals Ltd was used as the reference preparation for human bioequivalence testing. The bioequivalence of the two preparations was evaluated by comparing the pharmacodynamic parameters of the two preparations. (3) Fluticasone propionate cream (specification: 0.05%) provided by Hubei Bio-Pharmaceutical Industry Technology Research Institute Co., Ltd. was used as the test preparation, and fluticasone propionate cream (specification: 0.05%) certified by Padagis Israel Pharmaceuticals Ltd was used as the reference preparation. The in vivo exposure ratio of the test preparation and the reference preparation after topical administration was studied to evaluate the safety of the test preparation.

Start Date20 Oct 2024

Sponsor / Collaborator

Hubei Bio-Pharmaceutical Industrial Technological Institute

CTR20233777

/ RecruitingPhase 2

在成人慢性自发性荨麻疹患者中探索HWH486的有效性、安全性及药代动力学特征的多中心、随机、双盲、安慰剂对照的IIa期研究

[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase IIa study to explore the efficacy, safety and pharmacokinetic characteristics of HWH486 in adult patients with chronic spontaneous urticaria

探索HWH486在成人慢性自发性荨麻疹患者中的有效性、安全性及药代动力学特征

[Translation]

To explore the efficacy, safety and pharmacokinetic characteristics of HWH486 in adult patients with chronic spontaneous urticaria

Start Date13 Jan 2024

Sponsor / Collaborator

Hubei Bio-Pharmaceutical Industrial Technological Institute

CTR20232439

/ RecruitingPhase 2

HW021199片治疗特发性肺纤维化的多中心、随机、双盲、安慰剂对照、剂量探索IIa期临床试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled, dose-finding phase IIa clinical trial of HW021199 tablets for the treatment of idiopathic pulmonary fibrosis

1、探索HW021199片治疗特发性肺纤维化的推荐剂量； 2、初步评估HW021199片治疗特发性肺纤维化的有效性和安全性； 3、评估HW021199片用于特发性肺纤维化患者的药代动力学和药效动力学特征。

[Translation]

1. Explore the recommended dose of HW021199 tablets for the treatment of idiopathic pulmonary fibrosis; 2. Preliminary evaluation of the efficacy and safety of HW021199 tablets in the treatment of idiopathic pulmonary fibrosis; 3. Evaluate the pharmacokinetic and pharmacodynamic characteristics of HW021199 tablets in patients with idiopathic pulmonary fibrosis.

Start Date25 Dec 2023

Sponsor / Collaborator

Hubei Bio-Pharmaceutical Industrial Technological Institute

[+1]

100 Clinical Results associated with Hubei Bio-Pharmaceutical Industrial Technological Institute

0 Patents (Medical) associated with Hubei Bio-Pharmaceutical Industrial Technological Institute

Literatures (Medical) associated with Hubei Bio-Pharmaceutical Industrial Technological Institute

14 Dec 2023·ACS Medicinal Chemistry Letters

Discovery of Potent and Oral Bioavailable MAT2A Inhibitors for the Treatment of MTAP-Deleted Tumors

Article

Author: Liu, Lifei ; An, Dan ; Zhang, Xuejun ; Yang, Jun ; Li, Qun ; Jiang, Wen ; Su, Jiangtao ; Zang, Yang ; Li, Lie ; Liu, Rongchen

Inhibition of methionine adenosyltransferase 2A (MAT2A) has received significant interest because of its implication as a synthetic lethal target in methylthioadenosine phosphorylase (MTAP)-deleted cancers. Here, we report the discovery of a series of 3H-pyrido[1,2-c]pyrimidin-3-one derivatives as novel MAT2A inhibitors. The selected compound 30 exhibited high potency for MAT2A inhibition and a favorable pharmacokinetic profile. Furthermore, in an HCT-116 MTAP-deleted xenograft model, compound 30 showed better in vivo potency than current clinical compound AG-270.

01 Mar 2018·GeneQ3 · BIOLOGY

Long non-coding RNA FOXD2-AS1 aggravates nasopharyngeal carcinoma carcinogenesis by modulating miR-363-5p/S100A1 pathway

Q3 · BIOLOGY

Article

Author: Zeng, Wei ; Yang, Lijing ; Chen, Gang ; Sun, Wenjie ; Hua, Xinying

Long non-coding RNAs (lncRNAs) have been wildly verified to modulate multiple tumorigenesis, especially nasopharyngeal carcinoma (NPC). In present study, we aim to investigate the role of lncRNA FOXD2-AS1 in the NPC carcinogenesis. It was indicated that FOXD2-AS1 was markedly increased in NPC tissues and cells in comparison to their corresponding controls. Moreover, the aberrant overexpression of FOXD2-AS1 indicated the poor prognosis of NPC patients. Silence of FOXD2-AS1 was able to repress NPC cell growth in vitro while overexpression of FOXD2-AS1 inversed this process. Moreover, in vivo tumor xenografts were established using CNE-1/SUNE-1 cells to investigate the function of FOXD2-AS1 in NSCLC tumorigenesis. Rescue assay was performed to further confirm that FOXD2-AS1 contributed to NPC progression by regulating miR-363-5p/S100A1 signal pathway. Taken together, our study discovered the oncogenic role of FOXD2-AS1 in clinical specimens and cellular experiments, showing the potential FOXD2-AS1/miR-363-5p/S100A1 pathway. This results and findings provide a novel insight for NPC tumorigenesis.

01 May 2016·The Journal of Immunology

Discovery of WX486 as a novel, potent, selective, and orally bioavailable irreversible inhibitor of BTK

Author: Hu, Guoping ; Wang, Xuehai ; Shen, Chunli ; Wu, Chengde ; Xu, Yong ; Zhu, Yuchuan ; Chen, Hailiang ; Xiao, Qiang ; Chen, Shuhui ; Lin, Jian ; Huang, Lu ; Tu, Ronghua

AbstractBruton’s tyrosine kinase (BTK) has emerged as an attractive target for therapeutic intervention in human malignancies and autoimmune disorders, such as rheumatoid arthritis. Compounds were designed and evaluated in CADD based on published crystal structure. Selected compounds were synthesized and evaluated by BTK enzymatic assay. A chemical series where the central ring of ibrutinib was replaced by a bioisosteric motif showed strong enzyme inhibition activity. Further SAR of terminal aryl ring and Michael acceptor in terms of enzymatic activity, DMPK, hERG activity, and solubility was conducted. As a result, WX486 was identified as a potent (IC50=2.1 nM), selective (200~5000-fold over other 24 kinases), orally bioavailable (F=26.2%, 42.7%, 40.8% for mice, rats, and dogs, respectively), and soluble (solubility=266.40, 214.47, 209.01 μM at pH 2.5, 6.5, 7.4 respectively) preclinical candidate.

100 Deals associated with Hubei Bio-Pharmaceutical Industrial Technological Institute

100 Translational Medicine associated with Hubei Bio-Pharmaceutical Industrial Technological Institute

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Pipeline

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Preclinical

IND Approval

Phase 2 Clinical

Current Projects

Drug(Targets)	Indications	Global Highest Phase

HW021199 ( autotaxin )	Idiopathic Pulmonary Fibrosis More	Phase 2
HWH-340 ( PARP )	Castration-sensitive prostate cancer More	IND Approval
Mat2A inhibitors(Hubei Bio-Pharmaceutical Industrial Technological Institute) ( Mat2A )	Neoplasms More	Preclinical

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