Top 5 Target	Count

CDK4 x CDK6	1
PDE5A(Phosphodiesterase 5A)	1
PBPs(Bacterial penicillin-binding protein)	1
DPP-4(Dipeptidyl peptidase IV)	1
PARP7(TCDD-inducible poly [ADP-ribose] polymerase)	1

Drugs associated with Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

Birociclib

Target

CDK4 x CDK6

Mechanism

CDK4 inhibitors [+1]

Active Org.

Xuanzhu Biopharmaceutical Co., Ltd.Startup [+3]

Originator Org.

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

Active Indication

Hormone receptor positive HER2 negative breast cancer [+2]

Inactive Indication-

Drug Highest PhaseNDA/BLA

First Approval Ctry. / Loc.-

First Approval Date-

XZP-3621

Target

ALK x ROS1

Mechanism

ALK inhibitors [+1]

Active Org.

Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd. [+2]

Originator Org.

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

Active Indication

ALK positive Non-Small Cell Lung Cancer [+2]

Inactive Indication-

Drug Highest PhaseNDA/BLA

First Approval Ctry. / Loc.-

First Approval Date-

Benapenem

Target

PBPs

Mechanism

PBPs inhibitors [+1]

Active Org.

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd. [+1]

Originator Org.

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

Active Indication

Urinary Tract Infections [+3]

Inactive Indication

Bacterial Infections [+5]

Drug Highest PhasePhase 2/3

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

CTR20231226

/ CompletedPhase 1

[14C]XZP-3621在中国健康受试者体内的物质平衡I期临床试验

[Translation] Phase I clinical trial of [14C]XZP-3621 in healthy Chinese subjects: a study on the mass balance

主要目的：定量分析健康受试者单次口服[14C]XZP-3621后排泄物的总放射性，获得人体内物质平衡数据及主要排泄途径；定量分析健康受试者单次口服[14C]XZP-3621后全血与血浆总放射性、获得血浆中总放射性的药代动力学参数，并考察全血和血浆总放射性的分配情况；考察健康受试者单次口服[14C]XZP-3621后血浆、尿液和粪便中的放射性代谢物谱，并鉴定主要代谢产物，提供XZP-3621在人体内主要代谢途径及消除途径。次要目的：采用已验证的液相色谱串联质谱法（LC-MS/MS）定量分析血浆中XZP-3621、代谢产物XZP-5089及其他代谢产物（如适用）的浓度，获得血浆中XZP-3621、代谢产物XZP-5089及其他代谢产物（如适用）的药代动力学参数。评估健康受试者单次口服[14C]XZP-3621的安全性。

[Translation]

Main purpose: Quantitatively analyze the total radioactivity in excreta after a single oral administration of [14C]XZP-3621 in healthy subjects, and obtain the material balance data and main excretion pathways in the human body; Quantitatively analyze the total radioactivity in whole blood and plasma after a single oral administration of [14C]XZP-3621 in healthy subjects, obtain the pharmacokinetic parameters of total radioactivity in plasma, and investigate the distribution of total radioactivity in whole blood and plasma; Investigate the radioactive metabolite spectrum in plasma, urine and feces of healthy subjects after a single oral administration of [14C]XZP-3621, identify the main metabolites, and provide the main metabolic pathways and elimination pathways of XZP-3621 in the human body. Secondary purpose: Use the validated liquid chromatography tandem mass spectrometry (LC-MS/MS) to quantitatively analyze the concentrations of XZP-3621, metabolite XZP-5089 and other metabolites (if applicable) in plasma, and obtain the pharmacokinetic parameters of XZP-3621, metabolite XZP-5089 and other metabolites (if applicable) in plasma. To evaluate the safety of a single oral dose of [14C]XZP-3621 in healthy subjects.

Start Date05 Jun 2023

Sponsor / Collaborator

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

CTR20222649

/ CompletedPhase 1

一项在健康受试者中评价伊曲康唑或利福平或艾司奥美拉唑对XZP-3621片的药代动力学影响的药物-药物相互作用研究

[Translation] A drug-drug interaction study to evaluate the effects of itraconazole, rifampicin, or esomeprazole on the pharmacokinetics of XZP-3621 tablets in healthy subjects

主要目的： 1. 评估在健康志愿者中伊曲康唑对XZP-3621片的药代动力学影响； 2. 评估在健康志愿者中利福平对XZP-3621片的药代动力学影响； 3. 评估在健康志愿者中艾司奥美拉唑对XZP-3621片的药代动力学影响；次要目的： 1. 评估在健康志愿者中XZP-3621单药以及联用伊曲康唑的安全性。 2. 评估在健康志愿者中XZP-3621单药以及联用利福平的安全性。 3. 评估在健康志愿者中XZP-3621单药以及联用艾司奥美拉唑的安全性。

[Translation]

Primary objectives: 1. To evaluate the effect of itraconazole on the pharmacokinetics of XZP-3621 tablets in healthy volunteers; 2. To evaluate the effect of rifampicin on the pharmacokinetics of XZP-3621 tablets in healthy volunteers; 3. To evaluate the effect of esomeprazole on the pharmacokinetics of XZP-3621 tablets in healthy volunteers; Secondary objectives: 1. To evaluate the safety of XZP-3621 alone and in combination with itraconazole in healthy volunteers. 2. To evaluate the safety of XZP-3621 alone and in combination with rifampicin in healthy volunteers. 3. To evaluate the safety of XZP-3621 alone and in combination with esomeprazole in healthy volunteers.

Start Date25 Nov 2022

Sponsor / Collaborator

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

CTR20221799

/ CompletedPhase 1

[14C]吡罗西尼在中国男性健康受试者体内的物质平衡与生物转化研究

[Translation] Study on the substance balance and biotransformation of [14C]birocilide in healthy Chinese male subjects

考察[14C]吡罗西尼在健康受试者全血和血浆的分配情况以及全血和血浆中总放射性的药代动力学特征；定量分析健康受试者单次口服[14C]吡罗西尼后排泄物的总放射性，获得人体内物质平衡数据及主要排泄途径；评估健康受试者单次口服[14C]吡罗西尼的安全性。

[Translation]

To investigate the distribution of [14C]birocin in whole blood and plasma of healthy subjects and the pharmacokinetic characteristics of total radioactivity in whole blood and plasma; Quantitatively analyze the total radioactivity excreted in healthy subjects after a single oral administration of [14C]birocin to obtain material balance data and main excretion pathways in the human body; Evaluate the safety of a single oral administration of [14C]birocin to healthy subjects.

Start Date10 Nov 2022

Sponsor / Collaborator

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

[+1]

100 Clinical Results associated with Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

0 Patents (Medical) associated with Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

Literatures (Medical) associated with Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

01 Apr 2020·European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical SciencesQ2 · MEDICINE

Translational prediction of first-in-human pharmacokinetics and pharmacodynamics of janagliflozin, a selective SGLT2 inhibitor, using allometric scaling, dedrick and PK/PD modeling methods

Q2 · MEDICINE

Article

Author: Wen Zhong ; Chongtie Shi ; Kaiqi Zong ; Dongyang Liu ; Chuanxiang Ma ; Yang Liu ; Ling Song ; Huimin Zhou ; Hongzhong Liu ; Chong Wang ; Ji Jiang ; Xueting Yao ; Pei Hu

AIM:

Janagliflozin is an orally selective SGLT2 inhibitor. To predict human pharmacokinetics/pharmacodynamics (PK/PD) characteristics of janagliflozin. To design optimal starting dose and effective dose for janagliflozin first-in-human (FIH) study.

METHODS:

Animal PK/PD properties of janagliflozin were obtained from preclinical in vivo and in vitro study. Pharmacologically effective level of same class SGLT2 inhibitors were assessed through preclinical and clinical efficacy data of dapagliflozin, empagliflozin and canagliflozin. Human PK parameters and profiles of janagliflozin were predicted by various methods such as allometric scaling (AS), dedrick and PK/PD modeling analysis. Mechanistic PK/PD model was developed to describe janagliflozin-mediated impact on urinary glucose excretion (UGE). Human IC₅₀ was scaled from rat model-estimated IC₅₀ by correcting interspecies difference of in vitro IC₅₀ and plasma f_u of rat and human. The quantitative PK/PD prediction of janagliflozin was evaluated via observed PK/PD profiles of healthy subjects. Predicted PK/PD characteristics of janagliflozin were applied in FIH dose design. Optimal starting dose was suggested by considering preclinical PD and toxicity data of janagliflozin. Effective dose was suggested by considering pharmacologically effective level of same class drugs.

RESULTS:

PK/PD characteristics of janagliflozin in preclinical species were summarized. Pharmacologically effective level for SGLT2 inhibitors was defined as 25~30% ΔUGE (ΔUGE=--(PG*GFR)_within24h) based on efficacy data of three same class drugs. Human predicted CL, V_ss and F were 1.04 L/h, 77.5 L and 0.80. Predicted AUC and C_max of janagliflozin of 10 and 50 mg were within 0.47~2.08 fold of observed values. Predicted human UGE_0-24 h and UGE_0-144 h of 10 and 50 mg dose range were within 0.66~1.41 fold of observed values. Optimal starting dose and pharmacologically active dose (PAD) were suggested as 10 mg and 50 mg. Dose range for FIH study was designed as 10-450 mg.

CONCLUSIONS:

This study predicted human PK/PD characteristics of janagliflozin based on preclinical data and provide optimal dose design for janagliflozin FIH study based on pharmacologically effective level of same class drugs.

21 Feb 2020·Antimicrobial agents and chemotherapyQ2 · MEDICINE

Model-Informed Drug Development, Pharmacokinetic/Pharmacodynamic Cutoff Value Determination, and Antibacterial Efficacy of Benapenem against Enterobacteriaceae

Q2 · MEDICINE

Article

Author: Zhu, Xiao ; Lv, Yuan ; Kang, Zi-sheng ; Ji, Xi-wei ; Zhong, Wei ; Kuan, Isabelle Hui-san ; Xue, Feng ; Li, Yun ; Yang, Xi-ping

Benapenem is a novel carbapenem. The objective of this study was to determine the pharmacokinetic (PK)/pharmacodynamic (PD) cutoff values and evaluate the optimal administration regimens of benapenem for the treatment of bacterial infections via PK/PD modeling and simulation. Ertapenem was used as a control. Infected mice received an intravenous (i.v.) injection of benapenem or ertapenem of 14.6, 58.4, or 233.6 mg/kg of body weight, and the PK/PD profiles were evaluated.

01 Sep 2018·BioanalysisQ4 · MEDICINE

Development of an HPLC–MS/MS Method to Determine Janagliflozin in Human Plasma and Urine: Application in Clinical Study

Q4 · MEDICINE

Article

Author: Liu, Dongyang ; Jiang, Ji ; Shih, Chengkon ; Ma, Xifeng ; Liu, Hongzhong ; Zhou, Huimin ; Yao, Xueting ; Chen, Xijing ; Liu, Yang ; Song, Ling ; Chen, Bo ; Hu, Pei

Aim: Janagliflozin is a novel, orally selective sodium-glucose co-transporter-2 (SGLT2) inhibitor, which showed good efficacy and safety in preclinical study. The objective of this study is to develop and validate the HPLC–MS/MS method to determine janagliflozin in both of human urine and plasma. Methods: Janagliflozin was separated on Waters Xbridge Phenyl C18 column and detected on API 4000 tandem mass spectrometer with ESI source in negative mode. Results: This method provided good linearity in the range of 5–5000 ng/ml and 5–1000 ng/ml in plasma and urine. The matrix effect and extraction recoveries across three concentration levels were consistent. Conclusion: This validated method is reliable and has been successfully applied to a first-in-human trial of janagliflozin in Chinese subjects.

100 Deals associated with Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

100 Translational Medicine associated with Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

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Pipeline

Pipeline Snapshot as of 22 Mar 2025

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

Discovery

Preclinical

Phase 1

Phase 2

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Fadanafil ( PDE5A )	Erectile Dysfunction More	Phase 2
Imigliptin Hydrochloride ( DPP-4 )	Diabetes Mellitus, Type 2 More	Phase 2
XZP-3621 ( ALK x ROS1 )	Non-Small Cell Lung Cancer More	Phase 1
Birociclib ( CDK4 x CDK6 )	Advanced Malignant Solid Neoplasm More	Phase 1
KM254-ADC	Colorectal Cancer More	Preclinical

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