Delving into the Latest Updates on Hainan Huiyuantang Pharmaceutical Co Ltd with Synapse

Overview

Basic Info

Introduction

Hui Yuan Tang Pharmaceutical Co., Ltd. is nestled on Hainan Island and specializes in the modern production of pure and natural traditional Chinese medicine (TCM) with an emphasis on environmentally friendly high-tech processes. Established in 1994, the enterprise was originally part of the publicly traded company Hainan Zhongtung High-Tech Materials Co., Ltd.

Tags

Skin and Musculoskeletal Diseases

Infectious Diseases

Urogenital Diseases

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Infectious Diseases	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

PP2A(Protein phosphatase 2A)	1

主要目的：以洛索洛芬的主要药代动力学参数（AUC和Cmax）为生物等效性的评价指标，在中国健康受试者外用条件下评估受试制剂【海南回元堂药业有限公司生产的洛索洛芬钠贴剂，规格：100mg/贴（10cm x 14cm）】和参比制剂【Lead Chemical Co., Ltd持证的洛索洛芬钠贴剂，规格：100mg/贴（10cm x 14cm），商品名：乐松®】的生物等效性。次要目的：观察外用条件下受试制剂和参比制剂的黏附性、刺激性和安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the test formulation [Loxoprofen sodium patch manufactured by Hainan Huiyuantang Pharmaceutical Co., Ltd., specification: 100mg/patch (10cm x 14cm)] and the reference formulation [Loxoprofen sodium patch certified by Lead Chemical Co., Ltd., specification: 100mg/patch (10cm x 14cm), trade name: Lesong®] under topical application conditions in healthy Chinese subjects, using the main pharmacokinetic parameters (AUC and Cmax) as bioequivalence indicators. Secondary objective: To observe the adhesion, irritation, and safety of the test and reference formulations under topical application conditions.

Start Date20 Jan 2026

Sponsor / Collaborator

Hainan Huiyuantang Pharmaceutical Co Ltd

CTR20255184

/ CompletedNot Applicable

吲哚美辛凝胶贴膏在中国健康受试者外用条件下的单中心、随机、开放、两制剂、两周期、两序列、单次给药、交叉设计生物等效性研究

[Translation] A single-center, randomized, open-label, two-formulation, two-period, two-sequence, single-dose, crossover design bioequivalence study of indomethacin gel patch in healthy Chinese subjects under topical application conditions.

主要目的：以吲哚美辛的主要药代动力学参数（AUC和Cmax）为生物等效性的评价指标，在中国健康受试者外用条件下评估受试制剂【海南回元堂药业有限公司申报的吲哚美辛凝胶贴膏，规格：每贴（14cm×10cm）含膏体14g，含吲哚美辛70mg】和参比制剂【帝國製薬株式会社持证的吲哚美辛凝胶贴膏剂，规格：每贴（14cm×10cm）含膏体14g，含吲哚美辛70mg；商品名：Catlep®】的生物等效性。次要目的：观察外用条件下受试制剂和参比制剂的黏附性、皮肤刺激性和安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the test formulation [Indomethacin Gel Patch (application submitted by Hainan Huiyuantang Pharmaceutical Co., Ltd., specification: 14g of ointment per patch (14cm×10cm), containing 70mg of indomethacin)] and the reference formulation [Indomethacin Gel Patch (licensed by Teikoku Pharmaceutical Co., Ltd., specification: 14g of ointment per patch (14cm×10cm), containing 70mg of indomethacin; trade name: Catlep®)] under topical application conditions in healthy Chinese subjects, using the main pharmacokinetic parameters (AUC and Cmax) of indomethacin as bioequivalence indicators. Secondary objective: To observe the adhesion, skin irritation, and safety of the test and reference formulations under topical application conditions.

Start Date29 Dec 2025

Sponsor / Collaborator

Hainan Huiyuantang Pharmaceutical Co Ltd

CTR20254039

/ RecruitingPhase 3

吲哚美辛凝胶贴膏治疗膝骨关节炎有效性和安全性的多中心、随机、双盲、阳性药/安慰剂平行对照临床试验

[Translation] A multicenter, randomized, double-blind, active/placebo-controlled clinical trial on the efficacy and safety of indomethacin gel patch in the treatment of knee osteoarthritis

主要目的：以原研药为阳性对照，评价吲哚美辛凝胶贴膏治疗膝骨关节炎的临床疗效一致性；以安慰剂为对照，评价吲哚美辛凝胶贴膏治疗膝骨关节炎的优效性。次要目的：评价吲哚美辛凝胶贴膏在膝骨关节炎患者中的安全性。

[Translation]

Primary objective: To evaluate the consistency of clinical efficacy of indomethacin gel patch in the treatment of knee osteoarthritis using the original drug as a positive control; and to evaluate the superiority of indomethacin gel patch in the treatment of knee osteoarthritis using placebo as a control. Secondary objective: To evaluate the safety of indomethacin gel patch in patients with knee osteoarthritis.

Start Date11 Nov 2025

Sponsor / Collaborator

Hainan Huiyuantang Pharmaceutical Co Ltd

100 Clinical Results associated with Hainan Huiyuantang Pharmaceutical Co Ltd

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0 Patents (Medical) associated with Hainan Huiyuantang Pharmaceutical Co Ltd

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100 Deals associated with Hainan Huiyuantang Pharmaceutical Co Ltd

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100 Translational Medicine associated with Hainan Huiyuantang Pharmaceutical Co Ltd

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Pipeline

Pipeline Snapshot as of 31 Mar 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

Approved

1

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