Delving into the Latest Updates on Nanjing Zeheng Pharmaceutical Technology Development Co., Ltd. with Synapse

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Skin and Musculoskeletal Diseases

Infectious Diseases

Urogenital Diseases

Small molecule drug

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Disease Domain	Count

Infectious Diseases	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

fungal CYP51A1	1

主要目的：以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂呋塞米片（持证商：江苏润恒制药有限公司）与参比制剂呋塞米片(持证商:Validus Pharmaceuticals LLC.，商品名:LASIX®)后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的:观察受试制剂呋塞米片和参比制剂呋塞米片在健康受试者中的安全性。

[Translation]

Primary objective: To compare the pharmacokinetic behavior of the test preparation furosemide tablets (licensed by: Jiangsu Runheng Pharmaceutical Co., Ltd.) and the reference preparation furosemide tablets (licensed by: Validus Pharmaceuticals LLC., trade name: LASIX®) in healthy subjects after oral administration in the fasting/postprandial state, using pharmacokinetic parameters as the primary endpoint evaluation indicators, and to evaluate the bioequivalence of the two preparations. Secondary objective: To observe the safety of the test preparation furosemide tablets and the reference preparation furosemide tablets in healthy subjects.

Start Date02 Dec 2024

Sponsor / Collaborator

Jiangsu Runheng Pharmaceutical Co., Ltd

CTR20243596

/ CompletedNot Applicable

南京泽恒医药技术开发有限公司研制的盐酸美西律片与KYOWA CritiCare Co., Ltd公司持证的盐酸美西律片（商品名：Mexiletine Hydrochloride ®，规格：50 mg）在中国健康受试者中进行的随机、开放、单次给药、两周期、两序列、交叉、空腹及餐后状态下的生物等效性研究

[Translation] A randomized, open-label, single-dose, two-period, two-sequence, crossover, fasting and fed bioequivalence study of mexiletine hydrochloride tablets developed by Nanjing Zeheng Pharmaceutical Technology Development Co., Ltd. and mexiletine hydrochloride tablets (trade name: Mexiletine Hydrochloride ®, specification: 50 mg) licensed by KYOWA CritiCare Co., Ltd. in healthy Chinese subjects

以南京泽恒医药技术开发有限公司研制的盐酸美西律片（规格：50 mg）为受试制剂，以持证商为KYOWA CritiCare Co., Ltd公司的盐酸美西律片（商品名：Mexiletine Hydrochloride®，规格：50 mg）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。

[Translation]

Mexiletine Hydrochloride Tablets (Specification: 50 mg) developed by Nanjing Zeheng Pharmaceutical Technology Development Co., Ltd. were used as the test preparation, and Mexiletine Hydrochloride Tablets (trade name: Mexiletine Hydrochloride®, Specification: 50 mg) from KYOWA CritiCare Co., Ltd. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Start Date24 Oct 2024

Sponsor / Collaborator

Nanjing Zeheng Pharmaceutical Technology Development Co., Ltd.

CTR20233842

/ CompletedNot Applicable

甲氨蝶呤片在健康受试者中单中心、随机、开放、两制剂、单次给药、两周期、两序列、双交叉空腹/餐后生物等效性试验研究方案

[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-cycle, two-sequence, double-crossover fasting/fed bioequivalence study protocol for methotrexate tablets in healthy subjects

以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂甲氨蝶呤片（持证商：南京泽恒医药技术开发有限公司）与参比制剂甲氨蝶呤片（持证商：Pfizer Japan Inc.，商品名：METHOTREXATE）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。

[Translation]

Using pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behaviors of the test preparation methotrexate tablets (licensed by: Nanjing Zeheng Pharmaceutical Technology Development Co., Ltd.) and the reference preparation methotrexate tablets (licensed by: Pfizer Japan Inc., trade name: METHOTREXATE) in healthy subjects after oral administration in the fasting/postprandial state were compared to evaluate the bioequivalence of the two preparations.

Start Date03 Jan 2024

Sponsor / Collaborator

Nanjing Zeheng Pharmaceutical Technology Development Co., Ltd.

100 Clinical Results associated with Nanjing Zeheng Pharmaceutical Technology Development Co., Ltd.

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0 Patents (Medical) associated with Nanjing Zeheng Pharmaceutical Technology Development Co., Ltd.

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2

Literatures (Medical) associated with Nanjing Zeheng Pharmaceutical Technology Development Co., Ltd.

Yaowu Fenxi Zazhi

Determination of trace genotoxic impurities in furosemide and its preparations

Author: Zhao Ya-nan ; He Nian-ping ; Zhu Ya-fang ; Han Shu-xian

Objective:To establish an HPLC method for determining trace genotoxic impurities in furosemide and its preparationsMethods:The chromatog. column was filled with octadecylsilane bonded silica gel, with phosphoric acid solution and acetonitrile as mobile phase, and the detection wavelength was 270 nm.Results:The known impurities in the pharmacopoeia did not interfere with the detection.The detection limit of impurities was 12 ng·mL∼(-1).The linearity between 0.04-4.088 μg·mL∼(-1) was good, r∼2=1.000.The average recoveries of furosemide and its preparations were 99.8%(RSD=2.8%), 98.9%(RSD=0.9%)and 100.9%(RSD=2.4%).There were 0.003%-0.004% furfural detected in furosemide and its com. preparationsConclusion:This method has high specificity, sensitivity and good accuracy, and can be used to detect furfural, a trace gene toxin impurity in furosemide and its preparationsThis method ensures the efficacy and safety of furosemide preparations

Zhongguo Yiyao Gongye Zazhi

R&D Requirements and Consistency Evaluation of Topical Skin Preparations in in vitro and in vivo Tests

Author: Zhu Yafang ; Zhang Ziqiang ; Xu Cheng

100 Deals associated with Nanjing Zeheng Pharmaceutical Technology Development Co., Ltd.

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100 Translational Medicine associated with Nanjing Zeheng Pharmaceutical Technology Development Co., Ltd.

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Pipeline

Pipeline Snapshot as of 10 Feb 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

Phase 3 Clinical

1

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