Top 5 Target	Count

GABAA receptor(Gamma-aminobutyric acid A receptor)	1
PCSK9(Proprotein convertase subtilisin kexin type 9)	1
5-HT1A receptor x 5-HT2A receptor x D2 receptor	1
5-HT1A receptor x 5-HT2A receptor x D2 receptor x D3 receptor x DRDs	1
Lp(a)(lipoprotein(a))	1

Drugs associated with Zhejiang Jingxin Pharmaceutical Co., Ltd.

Dimdazenil

Target

GABAA receptor

Mechanism

GABAA receptor positive allosteric modulators

Active Org.

Zhejiang Jingxin Pharmaceutical Co., Ltd.

Originator Org.

Roche Holding AG

Active Indication

Sleep Initiation and Maintenance Disorders

Inactive Indication

Sleepiness

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date28 Nov 2023

Cariprazine hydrochloride

Target

5-HT1A receptor x 5-HT2A receptor x D2 receptor

Mechanism

5-HT1A receptor agonists [+2]

Active Org.

Gedeon Richter (UK) Ltd. [+6]

Originator Org.

Chemical Works of Gedeon Richter Plc

Active Indication

Depressive Disorder, Major [+9]

Inactive Indication

Chronic schizophrenia [+4]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date17 Sep 2015

Colesevelam Hydrochloride

Target

FABP6

Mechanism

FABP6 modulators

Active Org.

CHEPLAPHARM Arzneimittel GmbH [+3]

Originator Org.

Genzyme Corp.

Active Indication

Diabetes Mellitus, Type 2 [+3]

Inactive Indication

Diabetes Mellitus, Noninsulin-Dependent, 2 [+1]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date26 May 2000

Clinical Trials associated with Zhejiang Jingxin Pharmaceutical Co., Ltd.

CTR20242736 / CompletedNot Applicable

达格列净片在健康参与者中随机、开放、单剂量、两制剂、两序列、两周期交叉空腹/餐后状态下的生物等效性试验。

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of dapagliflozin tablets in healthy participants under fasting/fed conditions.

主要目的：研究空腹和餐后状态下单次口服受试制剂达格列净片（规格：10 mg，浙江京新药业股份有限公司生产）与参比制剂达格列净片（安达唐®，规格：10 mg，AstraZeneca AB持证、AstraZeneca Pharmaceuticals LP生产）在健康参与者体内的药代动力学特征，计算主要药动学参数，比较制剂间药动学参数AUC和Cmax的差异，评价受试制剂与参比制剂是否具有生物等效性。次要目的：研究空腹和餐后状态下单次口服受试制剂与参比制剂在中国健康参与者中的安全性。

[Translation]

Primary objective: To study the pharmacokinetic characteristics of the test preparation dapagliflozin tablets (specification: 10 mg, produced by Zhejiang Jingxin Pharmaceutical Co., Ltd.) and the reference preparation dapagliflozin tablets (Andatang®, specification: 10 mg, licensed by AstraZeneca AB, produced by AstraZeneca Pharmaceuticals LP) in healthy participants after a single oral administration in the fasting and fed state, calculate the main pharmacokinetic parameters, compare the differences in pharmacokinetic parameters AUC and Cmax between the preparations, and evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary objective: To study the safety of the test preparation and the reference preparation in Chinese healthy participants after a single oral administration in the fasting and fed state.

Start Date19 Aug 2024

Sponsor / Collaborator

Zhejiang Jingxin Pharmaceutical Co., Ltd.

CTR20242539 / CompletedNot Applicable

盐酸舍曲林分散片在健康成年参与者空腹状态下的单中心、开放、随机、单剂量、两周期、两序列、双交叉生物等效性试验

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, double-crossover bioequivalence study of sertraline hydrochloride dispersible tablets in healthy adult participants under fasting condition

主要试验目的：研究空腹状态下单次口服受试制剂盐酸舍曲林分散片（规格：50 mg，浙江京新药业股份有限公司生产）与参比制剂盐酸舍曲林片（左洛复®，规格：50 mg；辉瑞制药有限公司生产）在健康参与者体内的药代动力学特征，评价两种制剂是否具有生物等效性。次要试验目的：研究受试制剂盐酸舍曲林分散片（规格：50 mg，浙江京新药业股份有限公司生产）与参比制剂盐酸舍曲林片（左洛复®，规格：50 mg；辉瑞制药有限公司生产）在健康参与者中的安全性。

[Translation]

Main purpose of the study: To study the pharmacokinetic characteristics of the test preparation sertraline hydrochloride dispersible tablets (specification: 50 mg, produced by Zhejiang Jingxin Pharmaceutical Co., Ltd.) and the reference preparation sertraline hydrochloride tablets (Zoloft®, specification: 50 mg; produced by Pfizer Pharmaceuticals Co., Ltd.) in healthy participants after a single oral administration under fasting state, and to evaluate whether the two preparations are bioequivalent. Secondary purpose of the study: To study the safety of the test preparation sertraline hydrochloride dispersible tablets (specification: 50 mg, produced by Zhejiang Jingxin Pharmaceutical Co., Ltd.) and the reference preparation sertraline hydrochloride tablets (Zoloft®, specification: 50 mg; produced by Pfizer Pharmaceuticals Co., Ltd.) in healthy participants.

Start Date06 Aug 2024

Sponsor / Collaborator

Zhejiang Jingxin Pharmaceutical Co., Ltd.

CTR20242803 / RecruitingNot Applicable

评估受试制剂奥美拉唑肠溶片（规格：20 mg）与参比制剂奥美拉唑肠溶片（Omepral®，规格：20 mg）在健康成年参与者空腹及餐后状态下的生物等效性临床研究

[Translation] A clinical study to evaluate the bioequivalence of the test preparation, omeprazole enteric-coated tablets (strength: 20 mg), and the reference preparation, omeprazole enteric-coated tablets (Omepral®, strength: 20 mg), in healthy adult participants under fasting and fed conditions

主要目的：研究空腹及餐后状态下单次口服受试制剂奥美拉唑肠溶片（规格：20 mg，浙江京新药业股份有限公司生产）与参比制剂奥美拉唑肠溶片（Omepral®，规格：20 mg，太陽ファルマ株式会社持证）在健康成年参与者体内的药代动力学，评价两种制剂是否具有生物等效性。次要目的：研究受试制剂奥美拉唑肠溶片（规格：20 mg）和参比制剂奥美拉唑肠溶片（Omepral®，规格：20 mg）在健康成年参与者中的安全性。

[Translation]

Main purpose: To study the single oral administration of the test preparation omeprazole enteric-coated tablets (specification: 20 mg, produced by Zhejiang Jingxin Pharmaceutical Co., Ltd.) and the reference preparation omeprazole enteric-coated tablets in the fasting and postprandial state. (Omepral®, strength: 20 mg, licensed by Taiyo Fantasia Co., Ltd.) Pharmacokinetics in healthy adult participants to evaluate whether the two preparations are bioequivalent. Secondary purpose: To study the safety of the test preparation omeprazole enteric-coated tablets (strength: 20 mg) and the reference preparation omeprazole enteric-coated tablets (Omepral®, strength: 20 mg) in healthy adult participants .

Start Date02 Aug 2024

Sponsor / Collaborator

Zhejiang Jingxin Pharmaceutical Co., Ltd.

100 Clinical Results associated with Zhejiang Jingxin Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Zhejiang Jingxin Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Zhejiang Jingxin Pharmaceutical Co., Ltd.

01 May 2024·Crystal Growth & Design

Exploring the Solid-State Landscape of Atropisomers in (±)-Lesinurad: Insights into Crystallographic Analysis, Transformation Behavior, and Dissolution Performance

Author: Jin, Zhiping ; Hu, Xiurong ; Zhou, Xinbo ; Kang, Yanlei ; Ye, Jiali

Axial chirality is a unique form of chirality characterized by restricted rotation around a covalent bond due to steric or electronic hindrances, a phenomenon known as atropisomerism.The separation of (+)- and (-)-lesinurad from the racemic mixture suggests a potential advantage of (+)-lesinurad in treating hyperuricemia and gout due to its enhanced therapeutic efficacy.Although the crystalline structure profoundly affects a compound's physicochem. properties, the crystallog. landscapes of (+)- and (-)-lesinurad have yet to be explored.This study delves into the solid-state features of these atropisomers, identifying several novel polymorphic forms: two anhydrous polymorphs (forms A and B) and five solvates (SACE-H₂O, SETH, SNPA, SIPA, SMTBE) for (+)-lesinurad and one solvate for (-)-lesinurad, all characterized extensively.For the first time, the crystal structures of six solvates and form II of racemic lesinurad are elucidated using single-crystal diffraction, revealing that SACE-H₂O, SETH, SNPA, and SIPA are isostructural.Notably, form II of racemic lesinurad undergoes a reversible single-crystal to single-crystal transformation at around 94°C, transitioning between two polymorphs: a room-temperature variant (form II) and a high-temperature variant (form II-HT).Furthermore, we examined the equilibrium solubility and dissolution behavior of forms II, A, and B in a pH 6.8 aqueous solution, discovering enhanced solubility and dissolution rates for forms A and B compared with form II of racemic lesinurad.

08 Feb 2024·SLEEP

Efficacy and safety of Dimdazenil in the adult insomnia patients: a phase II randomized, multicenter, double-blind, placebo-controlled, and parallel-group study

Article

Author: Lin, Zhaocun ; Jiang, Yu ; Zhang, Ruoxi ; Bao, Cungang ; Guo, Sigen ; Li, Yanpeng ; Zhang, Min ; Chen, Chunyan ; Zhao, Zhongxin ; Song, Lihua ; Jin, Zhiping ; Zhou, Yanling ; He, Jingjing

AbstractStudy ObjectivesTo evaluate the efficacy and safety of Dimdazenil, a positive allosteric modulator with selectivity for α1, α5 subunit-containing GABAA receptors, on sleep variables in patients with insomnia disorder.MethodsIn this randomized, double-blind, placebo-controlled trial, adults (18–65 years) with insomnia disorder were randomized (1:1:1:1 to receive daily oral placebo, Dimdazenil (1.5, 2.5, or 5 mg) for 14 days. The primary efficacy outcome was the total sleep time (TST) on day 1/2 and day 13/14, measured by polysomnography. The secondary outcome measures included (1) latency to persistent sleep (LPS), sleep efficiency (SE), wake after sleep onset (WASO) and number of awakenings (NAW) on days 1/2 and day 13/14, and (2) the average subjective sleep latency (sSL), total sleep time (sTST), wake after sleep onset (sWASO) and number of awakenings (sNAW) recorded in sleep diary and sleep questionnaire, and the evaluation of insomnia severity index. Rebound insomnia, withdrawal, and treatment-emergent adverse events were also assessed.ResultsOf 569 patients screened, 288 (76.4% female) were randomized and received one dose. For the primary outcomes, TST was significantly improved in the Dimdazenil 1.5, 2.5, and 5 mg group compared with the placebo group at day 1/2, and significantly improved in the Dimdazenil 2.5 and 5 mg groups compared with the placebo group at day 13/14. The Least Squares Means (standard errors) and 95% Confidence Intervals for the three active doses compared to placebo are 25.5 (8.31), (9.16, 41.89) for the 1.5 mg dose; 17.4 (8.19), (1.29, 33.55) for the 2.5 mg dose; 22.8 (8.15), (6.72, 38.80) for the 5 mg dose on day 1/2. Corresponding data on day 13/14 are 7.6 (8.07), (−8.24, 23.53) and 19.3 (8.06), (3.43, 35.17) and 18.2 (7.95), (2.49, 33.80). LPS was significantly reduced in the Dimdazenil 5 mg group compared with the placebo group on day 1/2. SE was significantly improved in the Dimdazenil 1.5 and 5 mg group compared with the placebo group at day 1/2. In the subjective sleep parameters, sSL on average was significantly lower in the Dimdazenil 1.5, 2.5, and 5 mg groups compared with the placebo group. sTST on average was significantly higher in the Dimdazenil 1.5, 2.5, and 5 mg groups compared with the placebo group. The most common TEAEs were dizziness, vertigo, and weakness with no clinically relevant treatment-related serious adverse events.ConclusionsDimdazenil of 1.5, 2.5, and 5 mg improved certain objective and subjective sleep outcomes in people with insomnia disorder, with a favorable safety profile. These findings suggested that Dimdazenil may represent a promising new treatment for insomnia disorder, a prevalent condition with limited effective and safe treatments available.Clinical Trial InformationA multicenter, randomized, double-blind, multidose, placebo parallel controlled phase II clinical study of EVT201 in the treatment of insomnia disorders (http://www.chinadrugtrials.org), with the number of CTR20150664.

08 Feb 2024·SLEEP

Efficacy and safety of Dimdazenil in adults with insomnia disorder: results from a multicenter, randomized, double-blind, placebo-controlled phase III trials

Article

Author: Zhan, Shuqin ; He, Jingjing ; Zhang, Shengan ; Huang, Zhaoyang ; Zhou, Yanling ; Chen, Chunyan ; Wang, Yuping ; Zhao, Jianjun ; Zhu, Shuangpeng ; Jiang, Yu ; Lin, Zhaocun ; Bao, Cungang ; Zhang, Ruoxi

AbstractStudy ObjectivesTo evaluate the efficacy and safety of Dimdazenil, a novel partial positive allosteric modulator for GABAA receptor in adults with insomnia disorder.MethodsThis was a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase III study of Dimdazenil. The primary efficacy outcome was total sleep time (TST) analyzed by polysomnography (PSG) on day 13/14. Latency to persistent sleep (LPS), sleep efficiency (SE), and wake after sleep onset (WASO) were analyzed in the same way by polysomnography (PSG). The other secondary outcomes including the average subjective sleep latency (sSL), subjective TST (sTST), subjective SE (sSE), subjective WASO (sWASO), and subjective number of awakenings (sNAW) were analyzed from sleep diary data, and the insomnia severity index (ISI) was also assessed. Treatment-emergent adverse events (TEAEs) were monitored throughout the study.ResultsA total of 546 participants with insomnia (age ≥18 years) were randomized (2:1), received treatment with an oral dose of Dimdazenil (2.5 mg) or placebo, and analyzed. Compared to baseline and placebo, Dimdazenil demonstrated significant improvements in PSG measures, increased TST (71.09, 31.68 minutes, respectively; both p < 0.001), increased SE (13.26%, 5.55%, respectively; both < 0.001), reduced WASO (49.67, 20.16 minutes, respectively; both p < 0.001), and reduced LPS (21.65 minutes, p < 0.001; 6.46 minutes, p = 0.023). Compared to placebo, Dimdazenil also improved key self-reported measures of sTST (18.33 minutes, p < 0.001), sWASO (14.60 minutes, p < 0.001), sSL (4.23 minutes, p < 0.001), sSE (2.97%, p < 0.001), and sNAW (0.29, p < 0.001). Participants treated with Dimdazenil reported a significant improvement in ISI. Dimdazenil was well tolerated. The majority of TEAEs were mild or moderate. There were no clinically relevant treatment-related serious AEs and no deaths.ConclusionsDimdazenil of 2.5 mg provided significant benefit on sleep maintenance and sleep onset in individuals with insomnia disorder versus placebo, with a favorable safety profile and was well tolerated.Clinical Trial InformationA multicenter, randomized, double-blind phase III clinical study evaluating the efficacy and safety of EVT201 capsules compared to placebo in patients with insomnia disorders (http://www.chinadrugtrials.org), with the number of CTR20201068.

100 Deals associated with Zhejiang Jingxin Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Zhejiang Jingxin Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 22 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

Phase 3 Clinical

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Dimdazenil ( GABAA receptor )	Sleep Initiation and Maintenance Disorders More	Approved
Colesevelam Hydrochloride ( FABP6 )	-	Phase 3
Cariprazine hydrochloride ( 5-HT1A receptor x 5-HT2A receptor x D2 receptor )	-	Phase 3
Kangfuxin Enteric-coated Capsule	Colitis, Ulcerative More	Phase 2
JX11502MA ( 5-HT1A receptor x 5-HT2A receptor x D2 receptor x D3 receptor x DRDs )	Schizophrenia More	Phase 2

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