Delving into the Latest Updates on Guangzhou Nanxin Pharmaceutical Co. Ltd. with Synapse

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Cardiovascular Diseases

Respiratory Diseases

Infectious Diseases

Small molecule drug

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A glimpse into the focused therapeutic areas

Technology Platform

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Disease Domain	Count

Infectious Diseases	1

Top 5 Drug Type	Count

Small molecule drug	2

Top 5 Target	Count

influenza virus polymerase	1
ACE x NCC	1

主要研究目的：以广州南新制药有限公司生产的头孢泊肟酯干混悬剂为受试制剂，以Aurobindo Pharma Ltd的头孢泊肟酯干混悬剂为参比制剂，按 NMPA 颁布的《药物临床试验质量管理规范》、《以药动学参数为终点评价指标的化学药物仿制药人体生物等效性研究技术指导原则》等要求开展本项研究，测定血浆中头孢泊肟的浓度，研究受试制剂与参比制剂的吸收速度和吸收程度，评价两制剂在空腹及餐后条件下单次给药时的生物等效性。次要研究目的：观察两制剂在健康受试者中的安全性。

[Translation]

Main research purpose: Using the cefpodoxime axetil dry suspension produced by Guangzhou Nanxin Pharmaceutical Co., Ltd. as the test preparation and the cefpodoxime axetil dry suspension produced by Aurobindo Pharma Ltd as the reference preparation, this study was conducted in accordance with the "Good Clinical Practice for Drugs" and "Technical Guidelines for Human Bioequivalence Studies of Generic Chemical Drugs Using Pharmacokinetic Parameters as Endpoint Evaluation Indicators" issued by NMPA, to determine the concentration of cefpodoxime in plasma, study the absorption rate and degree of the test preparation and the reference preparation, and evaluate the bioequivalence of the two preparations when administered once under fasting and postprandial conditions. Secondary research purpose: To observe the safety of the two preparations in healthy subjects.

Start Date07 Dec 2021

Sponsor / Collaborator

Guangzhou Nanxin Pharmaceutical Co. Ltd.

CTR20201562

/ CompletedNot Applicable

贝那普利氢氯噻嗪片在中国成年健康受试者中的一项随机、开放、空腹和餐后单次给药、两制剂、两序列、两周期交叉的生物等效性研究

[Translation] A randomized, open-label, single-dose, fasting and fed, two-formulation, two-sequence, two-period crossover bioequivalence study of benazepril and hydrochlorothiazide tablets in healthy Chinese adult subjects

主要研究目的：分别在空腹和餐后条件下考察中国成年健康受试者单次口服1片受试制剂（贝那普利氢氯噻嗪片，规格：10mg/12.5mg/片，广州南新制药有限公司生产）与参比制剂（贝那普利氢氯噻嗪片，Lostenin HCT，规格：10mg/12.5mg/片，US Pharmaceuticalsholdings I LLC生产）的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为该药的申报及临床用药提供参考依据。次要研究目的：分别在空腹和餐后条件下评价中国成年健康受试者单次口服1片受试制剂和参比制剂的安全性。

[Translation]

The main purpose of the study is to investigate the relative bioavailability of a single oral tablet of the test preparation (benazepril hydrochlorothiazide tablets, specifications: 10mg/12.5mg/tablet, produced by Guangzhou Nanxin Pharmaceutical Co., Ltd.) and the reference preparation (benazepril hydrochlorothiazide tablets, Lostenin HCT, specifications: 10mg/12.5mg/tablet, produced by US Pharmaceuticalsholdings I LLC) in Chinese healthy adult subjects under fasting and postprandial conditions, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug. Secondary purpose of the study: To evaluate the safety of a single oral tablet of the test preparation and the reference preparation in Chinese healthy adult subjects under fasting and postprandial conditions.

Start Date03 Aug 2020

Sponsor / Collaborator

Guangzhou Nanxin Pharmaceutical Co. Ltd.

CTR20201258

/ CompletedNot Applicable

头孢呋辛酯分散片在健康受试者中随机、开放、两制剂、两周期、双交叉空腹/餐后状态下的生物等效性试验

[Translation] A randomized, open-label, two-dose, two-period, double-crossover bioequivalence study of cefuroxime axetil dispersible tablets in healthy subjects under fasting/fed conditions

以广州南新制药有限公司提供的头孢呋辛酯分散片（商品名：协诺信®，125 mg/片）为受试制剂，按生物等效性试验的有关规定，与Glaxo Smith Kline UK公司生产的头孢呋辛酯片（商品名：Zinnat®，参比制剂，125 mg/片）对比在健康人体内空腹/餐后给药条件下的相对生物利用度，考察两制剂的人体生物等效性。

[Translation]

Cefuroxime Axetil Dispersible Tablets (trade name: Zinnat®, 125 mg/tablet) provided by Guangzhou Nanxin Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant regulations of bioequivalence study, the relative bioavailability of the two preparations was compared with that of Cefuroxime Axetil Tablets (trade name: Zinnat®, reference preparation, 125 mg/tablet) produced by Glaxo Smith Kline UK under fasting/postprandial administration conditions in healthy humans, and the human bioequivalence of the two preparations was investigated.

Start Date13 Jul 2020

Sponsor / Collaborator

Guangzhou Nanxin Pharmaceutical Co. Ltd.

100 Clinical Results associated with Guangzhou Nanxin Pharmaceutical Co. Ltd.

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0 Patents (Medical) associated with Guangzhou Nanxin Pharmaceutical Co. Ltd.

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1

Literatures (Medical) associated with Guangzhou Nanxin Pharmaceutical Co. Ltd.

Frontiers in Pharmacology

A phase I, randomized study to evaluate the safety, tolerability, and pharmacokinetics of mefunidone in healthy subjects

Article

Author: Xiao, Chunyan ; Li, Jintong ; Bian, Zheng ; Cui, Gang ; Wang, Jing ; Wu, Wei ; Zhang, Shixi ; Lu, Xing ; Hu, Gaoyun ; Zhang, Xin ; Huo, Bishan ; Mi, Na ; Jin, Jiangli ; Han, Mai ; Wu, Bidong

Background:

Mefunidone is a novel synthetic compound and is better when compared to pirfenidone for the anti-fibrotic treatment of renal fibrosis in end-stage renal disease. We conducted this first-in-human, phase I clinical trial to determine the safety, tolerability, and pharmacokinetic (PK) (including food effect) profiles of mefunidone administered orally as single and multiple ascending doses in healthy subjects.

Methods:

Part A assessed single ascending doses of mefunidone from 25 mg to 800 mg or placebo once daily in the fasting state. Part A also assessed the effect of food on tolerability and PK in the 100 mg cohort. Part B consisted of three treatment groups who received 100 mg, 200 mg, or 400 mg of mefunidone or placebo twice daily (BID, bis in die) on days 1–6 and once in the morning on day 7.

Results:

Single oral doses of mefunidone up to 800 mg and multiple doses of mefunidone up to 400 mg BID were all well-tolerated. Mefunidone behaved with ideal dose proportionality within the single-dose range of 50 mg–600 mg and the multiple-dose range of 100 mg BID to 400 mg BID by day 7. High-fat fed conditions led to a delay in Tmax by approximately 1 h and a slight reduction of approximately 20% in Cmax compared to that in fasting conditions, but it did not significantly affect systemic exposure.

Conclusion:

Mefunidone exhibited favorable pharmacokinetics and safety profiles. The present study informed and supported further developmental clinical studies of mefunidone.

Clinical Trial Registration:

clinicaltrials.gov, identifier CXHL1900206

100 Deals associated with Guangzhou Nanxin Pharmaceutical Co. Ltd.

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100 Translational Medicine associated with Guangzhou Nanxin Pharmaceutical Co. Ltd.

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Pipeline

Pipeline Snapshot as of 06 Apr 2026

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

1

Approved

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Benazepril Hydrochloride/Hydrochlorothiazide ( ACE x NCC )	Hypertension More	Approved
NX-2016 ( influenza virus polymerase )	Influenza, Human More	Preclinical