Delving into the Latest Updates on Zhongshan Wanhan Pharmaceutical Co., Ltd. with Synapse

Overview

Tags

Congenital Disorders

Nervous System Diseases

Immune System Diseases

Synthetic peptide

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

Immune System Diseases	1
Infectious Diseases	1
Nervous System Diseases	1

Top 5 Drug Type	Count

Synthetic peptide	1
Small molecule drug	1

Top 5 Target	Count

COX(Cyclooxygenases)	1
GLP-1R(Glucagon-like peptide 1 receptor)	1

考察健康受试者多次服用由中山万汉制药有限公司提供的奥利司他胶囊（受试制剂T，规格：60mg）与由Glaxo SmithKline Consumer Healthcare持证的奥利司他胶囊（参比制剂R，商品名：Alli®，规格：60mg）的药效学差异，评价两制剂的生物等效性和安全性，为受试制剂的注册申请提供依据。

[Translation]

To investigate the pharmacodynamic differences between orlistat capsules (test preparation T, strength: 60 mg) provided by Zhongshan Wanhan Pharmaceutical Co., Ltd. and orlistat capsules (reference preparation R, trade name: Alli®, strength: 60 mg) certified by Glaxo SmithKline Consumer Healthcare after repeated administration in healthy subjects, evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation.

Start Date06 Oct 2024

Sponsor / Collaborator

Zhongshan Wanhan Pharmaceutical Co., Ltd.

CTR20242094 / RecruitingNot Applicable

磷酸奥司他韦颗粒在空腹及餐后条件下的人体生物等效性试验

[Translation] Bioequivalence study of oseltamivir phosphate granules in humans under fasting and fed conditions

考察健康受试者在空腹及餐后条件下，单次口服由中山万汉制药有限公司提供的磷酸奥司他韦颗粒【受试制剂，规格：3%（30g），以奥司他韦计】或由中外制药株式会社持证的磷酸奥司他韦干糖浆【参比制剂，商品名：Tamiflu®，规格：3%（30g），以奥司他韦计】的药动学特征，评价两制剂的生物等效性及安全性，为该受试制剂注册申请提供依据。

[Translation]

To investigate the pharmacokinetic characteristics of a single oral dose of oseltamivir phosphate granules [test preparation, specification: 3% (30g), calculated as oseltamivir] provided by Zhongshan Wanhan Pharmaceutical Co., Ltd. or oseltamivir phosphate dry syrup [reference preparation, trade name: Tamiflu®, specification: 3% (30g), calculated as oseltamivir] certified by Chugai Pharmaceutical Co., Ltd. in healthy subjects under fasting and postprandial conditions, evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation.

Start Date11 Jul 2024

Sponsor / Collaborator

Zhongshan Wanhan Pharmaceutical Co., Ltd.

CTR20233655 / CompletedNot Applicable

精氨酸布洛芬颗粒在空腹及餐后条件下的人体生物等效性试验

[Translation] Bioequivalence study of arginine ibuprofen granules in fasting and fed subjects

考察空腹及餐后条件下，健康受试者单次口服由中山万汉制药有限公司生产的精氨酸布洛芬颗粒（受试制剂，规格：0.4g，按布洛芬计）与相同条件下单次口服由海南赞邦制药有限公司的精氨酸布洛芬颗粒（参比制剂，商品名：司百得®，规格：0.4g，按布洛芬计）的药动学特征，评价两制剂间的生物等效性和安全性，为受试制剂的注册申请提供依据。

[Translation]

To investigate the pharmacokinetic characteristics of a single oral administration of arginine ibuprofen granules produced by Zhongshan Wanhan Pharmaceutical Co., Ltd. (test preparation, specification: 0.4g, calculated as ibuprofen) to healthy subjects under fasting and postprandial conditions and a single oral administration of arginine ibuprofen granules produced by Hainan Zanbang Pharmaceutical Co., Ltd. (reference preparation, trade name: SPECTREX®, specification: 0.4g, calculated as ibuprofen) under the same conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.

Start Date10 Dec 2023

Sponsor / Collaborator

Zhongshan Wanhan Pharmaceutical Co., Ltd.

100 Clinical Results associated with Zhongshan Wanhan Pharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Zhongshan Wanhan Pharmaceutical Co., Ltd.

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2

Literatures (Medical) associated with Zhongshan Wanhan Pharmaceutical Co., Ltd.

01 Jan 2018·European Journal of Pharmaceutical SciencesQ2 · MEDICINE

Development of a validated HPLC method for the quantitative determination of trelagliptin succinate and its related substances in pharmaceutical dosage forms

Q2 · MEDICINE

Article

Author: Wang, Guopeng ; Liu, Aoxue ; Chen, Xinjing ; Liu, Yang ; Yu, Guohua ; Li, Mengwei ; Peng, Wei ; Luo, Zhiqiang ; Du, Zhibo ; Wang, Hao ; Ma, Xiaoyun

Trelagliptin succinate is a dipeptidyl peptidase IV (DPP-4) inhibitor which is used as a new long-acting drug for once-weekly treatment of type 2 diabetes mellitus (DM). In the present study, a rapid, sensitive and accurate high-performance liquid chromatography (HPLC) method was developed and validated for separation and determination of trelagliptin succinate and its eight potential process-related impurities. The chromatographic separation was achieved on a Waters Xselect CSH™ C₁₈ (250mm×4.6mm, 5.0μm) column. The mobile phases comprised of 0.05% trifluoroacetic acid in water as well as acetonitrile containing 0.05% trifluoroacetic acid. The compounds of interest were monitored at 224nm and 275nm. The stability-indicating capability of this method was evaluated by performing stress test studies. Trelagliptin succinate was found to degrade significantly in acid, base, oxidative and thermal stress conditions and only stable in photolytic degradation condition. The degradation products were well resolved from the main peak and its impurities. In addition, the major degradation impurities formed under acid, base, oxidative and thermal stress conditions were characterized by ultra-high-performance liquid chromatography coupled with linear ion trap-Orbitrap tandem mass spectrometry (UHPLC-LTQ-Orbitrap). The method was validated to fulfill International Conference on Harmonisation (ICH) requirements and this validation included specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision and robustness. The developed method in this study could be applied for routine quality control analysis of trelagliptin succinate tablets, since there is no official monograph.

Expert Opinion on Therapeutic Patents

Therapeutic compounds targeting interleukin-1 receptor-associated kinase 4 (IRAK4): an updated patent review (2019 to present)

Review

Author: Xiang, Fei

BACKGROUNDIt is more than two decades since IRAK4, a promising target for therapies against various medical conditions, was first reported, but no compounds targeting this enzyme are active on the market or under late-stage clinical development. So it is necessary to continue exploring new and/or improved chemotypes for IRAK4-targeting compounds, to which updated patent reviews are supposed to be of considerable contribution.AREAS COVEREDPCT patents claiming IRAK4-targeting compounds and published through 2019 to present were retrieved, screened and reviewed for the title compounds disclosed therein, where chemotype-specific strategies were adopted for the said reviewing process. Included patents featuring non-Protac compounds were described in terms of generic formulas and variable-indicated moieties of the title compounds, as well as selected title compounds and relevant prior documents. Included patents featuring Protac-based compounds were described in terms of general examples of IRAK-binding moieties and ligase-binding moieties, as well as the presence of conventional linker types. Insights were finally extracted from the patent review.EXPERT OPINIONThe last five years has seen a steady increase in the number of PCT patents claiming IRAK4-targeting therapeutic compounds, with some of them being based on new chemotypes and/or discovered by new organizations as potential new players.

100 Deals associated with Zhongshan Wanhan Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Zhongshan Wanhan Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 29 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

IND Application

1

Phase 1 Clinical

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