Delving into the Latest Updates on Hunan Dongting Pharmaceutical Co., Ltd. with Synapse

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Congenital Disorders

Mouth and Tooth Diseases

Small molecule drug

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Disease Domain	Count

Nervous System Diseases	2
Infectious Diseases	2
Immune System Diseases	2
Hemic and Lymphatic Diseases	1

Top 5 Drug Type	Count

Small molecule drug	5

Top 5 Target	Count

NET x SERT	1
5-HT2A receptor x D2 receptor	1
GABAA receptor(Gamma-aminobutyric acid A receptor)	1
mAChRs(Muscarinic acetylcholine receptor)	1
PLG(Plasminogen)	1

本研究考察健康受试者在空腹及餐后条件下，单次口服由湖南洞庭药业股份有限公司生产的阿普唑仑片（受试制剂，规格：0.4 mg）或由ヴィアトリス製薬株式会社（Viatoris制药株式会社）持证的阿普唑仑片（参比制剂，商品名：Solanax®，规格：0.4 mg）的药动学特征，评价两制剂的生物等效性及安全性，该受试制剂一致性评价提供依据。

[Translation]

This study examined the oral administration of a single dose of alprazolam tablets (test preparation, specification: 0.4 mg) produced by Hunan Dongting Pharmaceutical Co., Ltd. or Alprazolam tablets produced by Biotech Co., Ltd. to healthy subjects under fasting and postprandial conditions. (Viatoris Pharmaceutical Co., Ltd.) Pharmacokinetic characteristics of certified alprazolam tablets (reference preparation, trade name: Solanax®, strength: 0.4 mg), to evaluate the bioequivalence and safety of the two preparations, which subject Provide a basis for consistency evaluation of trial preparations.

Start Date14 May 2024

Sponsor / Collaborator

Hunan Dongting Pharmaceutical Co., Ltd.

CTR20233017 / CompletedNot Applicable

米氮平片在健康受试者中随机、开放、两制剂、两周期、双交叉、空腹和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 mirtazapine tablets in healthy subjects under fasting and fed conditions

主要目的：以湖南洞庭药业股份有限公司提供的米氮平片（规格：15 mg）为受试制剂，ORGANON USA INC 持证的米氮平片（规格：15 mg，商品名：REMERON®）为参比制剂，比较在空腹及餐后给药条件下，受试制剂和参比制剂的药代动力学差异，评估两制剂的生物等效性。次要目的：评估受试制剂和参比制剂在健康受试者体内的安全性。

[Translation]

Primary objective: Using mirtazapine tablets (specification: 15 mg) provided by Hunan Dongting Pharmaceutical Co., Ltd. as the test preparation and mirtazapine tablets (specification: 15 mg, trade name: REMERON®) certified by ORGANON USA INC as the reference preparation, the pharmacokinetic differences between the test preparation and the reference preparation under fasting and postprandial administration conditions were compared to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of the test preparation and the reference preparation in healthy subjects.

Start Date22 Oct 2023

Sponsor / Collaborator

Hunan Dongting Pharmaceutical Co., Ltd.

CTR20230613 / CompletedNot Applicable

马来酸氟伏沙明片人体生物等效性研究

[Translation] Study on the bioequivalence of fluvoxamine maleate tablets in healthy volunteers

采用单中心、随机、开放、两周期、两序列、双交叉、单次口服试验设计比较空腹和餐后给药条件下，湖南洞庭药业股份有限公司生产的马来酸氟伏沙明片（50 mg）与Abbott Laboratories （Singapore） Private Limited（雅培）持证的马来酸氟伏沙明片（50 mg，商品名：Luvox®/兰释®）在中国健康人群吸收程度和吸收速度的差异，并评价湖南洞庭药业股份有限公司生产的马来酸氟伏沙明片的安全性。

[Translation]

A single-center, randomized, open, two-period, two-sequence, double-crossover, single-dose oral trial design was used to compare the differences in absorption extent and absorption rate between fluvoxamine maleate tablets (50 mg) produced by Hunan Dongting Pharmaceutical Co., Ltd. and fluvoxamine maleate tablets (50 mg, trade name: Luvox®/Lanshi®) certified by Abbott Laboratories (Singapore) Private Limited (Abbott) under fasting and fed dosing conditions in healthy Chinese people, and to evaluate the safety of fluvoxamine maleate tablets produced by Hunan Dongting Pharmaceutical Co., Ltd.

Start Date15 Apr 2023

Sponsor / Collaborator

Hunan Dongting Pharmaceutical Co., Ltd.

100 Clinical Results associated with Hunan Dongting Pharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Hunan Dongting Pharmaceutical Co., Ltd.

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8

Literatures (Medical) associated with Hunan Dongting Pharmaceutical Co., Ltd.

Jingxi Huagong Zhongjianti

Improved Synthesis of 2-(2-fluoro-4-biphenylyl)propionic acid

Author: Liu, Yinlong

2-(2-Fluoro-4-biphenylyl)propionic acid was synthesized from 4-acetyl-2-fluorobiphenyl by oxidation, esterification, condensation, hydrolysis and decarboxylation reaction.Inflammable ether was not used and vacuum distillation was omitted.The optimum conditions were: the dosage of sulfur powder 12 kg, temperature 115°-120° and time 50 min.The yield was increased by 5%.This method was simple, reasonable reliable, and it could be used in the industry on a large scale.

Guangdong Huagong

GC-FID-derivative Technique Determination of Methanesulfonic Acid Alkyl Ester in Escitalopram Oxalate

Author: Du Jian ; Hou Qiwei ; Hou Liangwei

Objective To establish a derivative gas chromatog. method simultaneously quant. determination of Me methanesulfonate(MMS), Et methanesulfonate(EMS),isopropyl methanesulfonate(IMS) in escitalopram oxalate. ethods: NaI-H2 O solution as the iodonation agent,DB-WAX(30 m*0.45 mm, 85 um) capillary column was used to sep. the fatty acids and FID for quant. determination esults: The linear range of Me iodide is 0.2784∼10.44 μg/mL the linear range of Iodoethane is 0.2944∼11.04 μg/mL the linear range of 2-iodopropane is 0.2608∼9.78 μg/mL.The method's specificity and accuracy meet the requirements.Conclusion: The method shows satisfactory repeatability, simplicity and convenience, and is valid in simultaneous derivation separation and anal. of these methanesulfonic acid alkyl ester in escitalopram oxalate.

Guangdong Huagong

Optimization of Synthesis of Key Intermediate of Quetiapine

Author: Sun Jiehua ; Liu Jing ; Wu Nanlin

In this paper, the synthesis process of quetiapine key intermediate chloride(11-chlorodibenzo [b, f] [1, 4] thiazapine) was optimized.10 H dibenzo [b, f] [1, 4] thiaaza-11-one and phosphorus oxychloride were used as raw materials, toluene as solvent and N, N-dimethylaniline as catalyst, The target product chloride was obtained by chlorination reaction.The yield and purity of quetiapine were 90 % and 99.5 %, resp.The process optimizes the feeding amount of phosphorus oxychloride, greatly improves the product yield, reduces the pressure for the later treatment of phosphorus containing wastewater, and is suitable for industrial production

100 Deals associated with Hunan Dongting Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Hunan Dongting Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 23 Dec 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

Approved

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Lorazepam ( GABAA receptor )	Anxiety Disorders More	Approved
Tranexamic Acid ( PLG )	Hemorrhage More	Approved
Clomipramine Hydrochloride ( NET x SERT )	Obsessive-Compulsive Disorder More	Approved
Glycopyrrolate ( mAChRs )	Stomach Ulcer More	Approved
Thioridazine Hydrochloride ( 5-HT2A receptor x D2 receptor )	Schizophrenia More	Approved