Top 5 Target	Count

CDK4 x CDK6	1
PDE5A(Phosphodiesterase 5A)	1
PBPs(Bacterial penicillin-binding protein)	1
GLP-1R(Glucagon-like peptide 1 receptor)	1
PARP(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.

[+2]

Originator Org.

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

Active Indication

Hormone receptor positive HER2 negative breast cancer [+3]

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

China

First Approval Date13 May 2025

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 [+1]

Inactive Indication-

Drug Highest PhaseNDA/BLA

First Approval Ctry. / Loc.-

First Approval Date-

Benapenem

Target

PBPs

Mechanism

PBPs inhibitors [+1]

Active Org.

Shanghai New Asiatic Pharmaceuticals 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.

CTR20211421

/ CompletedPhase 1

吡罗西尼片在健康受试者中的单中心、开放、药物相互作用试验

[Translation] A single-center, open-label, drug-drug interaction trial of piroxicam tablets in healthy subjects

主要目的：评估克拉霉素在健康志愿者中对吡罗西尼的药代动力学影响；评估利福平在健康志愿者中对吡罗西尼的药代动力学影响；次要目的：评估在健康志愿者中使用克拉霉素时吡罗西尼的安全性和耐受性；评估在健康志愿者中使用利福平时吡罗西尼的安全性和耐受性。

[Translation]

Primary objectives: To evaluate the effect of clarithromycin on the pharmacokinetics of pirocirib in healthy volunteers; To evaluate the effect of rifampicin on the pharmacokinetics of pirocirib in healthy volunteers; Secondary objectives: To evaluate the safety and tolerability of pirocirib when clarithromycin is used in healthy volunteers; To evaluate the safety and tolerability of pirocirib when rifampicin is used in healthy volunteers.

Start Date18 Jul 2021

Sponsor / Collaborator

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

[+1]

CTR20202033

/ TerminatedPhase 1/2

评价XZP-5809-TT1片在经表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗后进展的T790M突变阳性的局部晚期或转移性非小细胞肺癌患者中的安全性、耐受性、药代动力学特征及有效性的单臂、开放、多中心的I/II期临床试验

[Translation] A single-arm, open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and efficacy of XZP-5809-TT1 tablets in patients with T790M mutation-positive locally advanced or metastatic non-small cell lung cancer who have progressed after treatment with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs)

I期：主要目的：评价XZP-5809-TT1片在经表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗后进展的T790M突变阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者中的安全性和耐受性。次要目的：评价XZP-5809-TT1片及其主要代谢产物在经表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗后进展的T790M突变阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者中的药代动力学特征及有效性。 II期：主要目的：评价XZP-5809-TT1片在经EGFR-TKI治疗后进展T790M突变阳性的局部晚期或转移性NSCLC患者中的客观缓解率（ORR）。次要目的：评价XZP-5809-TT1片在经EGFR-TKI治疗后进展T790M突变阳性的局部晚期或转移性NSCLC患者中的有效性，安全性及药代动力学特征。 I/II期：探索性目的：初步探索血液ctDNA T790M突变与XZP-5809-TT1片的疗效关系以及XZP-5809-TT1的耐药机制。

[Translation]

Phase I: Primary purpose: To evaluate the safety and tolerability of XZP-5809-TT1 tablets in patients with T790M mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after treatment with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs). Secondary purpose: To evaluate the pharmacokinetic characteristics and efficacy of XZP-5809-TT1 tablets and its main metabolites in patients with T790M mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after treatment with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs). Phase II: Primary purpose: To evaluate the objective response rate (ORR) of XZP-5809-TT1 tablets in patients with T790M mutation-positive locally advanced or metastatic NSCLC who have progressed after treatment with EGFR-TKIs. Secondary purpose: To evaluate the efficacy, safety and pharmacokinetic characteristics of XZP-5809-TT1 tablets in patients with locally advanced or metastatic NSCLC who are positive for T790M mutation and progress after EGFR-TKI treatment. Phase I/II: Exploratory purpose: To preliminarily explore the relationship between blood ctDNA T790M mutation and the efficacy of XZP-5809-TT1 tablets and the resistance mechanism of XZP-5809-TT1.

Start Date02 Nov 2020

Sponsor / Collaborator

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

CTR20200880

/ CompletedPhase 1

安纳拉唑钠肠溶片、阿莫西林、克拉霉素、枸橼酸铋钾药代动力学相互作用单中心、随机、开放、交叉临床研究

[Translation] A single-center, randomized, open, crossover clinical study on the pharmacokinetic interaction between anaprazole sodium enteric-coated tablets, amoxicillin, clarithromycin, and bismuth potassium citrate

主要目的：评价安纳拉唑钠肠溶片、阿莫西林和克拉霉素三药同时口服后在中国健康受试者中的药代动力学相互作用；评价枸橼酸铋钾对三药联合PK的影响。次要目的：评价三药联合多次给药在中国健康受试者中的安全性及耐受性；评价三药联合枸橼酸铋钾单次给药在中国健康受试者中的安全性及耐受性。

[Translation]

Primary objectives: To evaluate the pharmacokinetic interaction of anaprazole sodium enteric-coated tablets, amoxicillin and clarithromycin after simultaneous oral administration in healthy Chinese subjects; to evaluate the effect of potassium citrate bismuth on the PK of the three-drug combination. Secondary objectives: To evaluate the safety and tolerability of the three-drug combination after multiple administration in healthy Chinese subjects; to evaluate the safety and tolerability of the three-drug combination after single administration in healthy Chinese subjects.

Start Date10 Aug 2020

Sponsor / Collaborator

Beijing Sihuan Pharmaceutical 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 ; Huimin Zhou ; Ling Song ; Hongzhong Liu ; Chong Wang ; Ji Jiang ; Pei Hu ; Xueting Yao

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 ; Li, Yun ; Xue, Feng ; 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 ; Ma, Xifeng ; Shih, Chengkon ; Yao, Xueting ; Liu, Hongzhong ; Zhou, Huimin ; 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 05 Jul 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 ( HER2 )	Colorectal Cancer More	Preclinical

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