Delving into the Latest Updates on Shanghai Boyue Biotechnology Co., Ltd. with Synapse

Overview

Tags

Neoplasms

Nervous System 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

Neoplasms	2
Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	2

Top 5 Target	Count

AXL x c-Met	1

主要目的：以上海博悦生物科技有限公司的盐酸乙哌立松片（规格：50mg；生产厂家：华益泰康药业股份有限公司）为受试制剂，以卫材（中国）药业有限公司的盐酸乙哌立松片（商品名：妙纳®，规格：50mg；生产厂家：卫材（中国）药业有限公司）为参比制剂，按生物等效性试验的有关规定，考察两制剂在健康人体内的生物等效性。次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Main purpose: Using Eperisone Hydrochloride Tablets (Specification: 50 mg; Manufacturer: Huayi Taikang Pharmaceutical Co., Ltd.) of Shanghai Boyue Biotechnology Co., Ltd. as the test preparation and Eperisone Hydrochloride Tablets (Trade name: Myona®, Specification: 50 mg; Manufacturer: Eisai (China) Pharmaceutical Co., Ltd.) of Eisai (China) Pharmaceutical Co., Ltd. as the reference preparation, according to the relevant provisions of the bioequivalence test, the bioequivalence of the two preparations in healthy humans was investigated. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date15 Nov 2024

Sponsor / Collaborator

Shanghai Boyue Biotechnology Co., Ltd.

CTR20243446

/ CompletedNot Applicable

盐酸乙哌立松片在健康受试者中的单剂量、随机、开放、完全重复交叉、两制剂、四周期餐后人体生物等效性试验

[Translation] A single-dose, randomized, open-label, completely repeated crossover, two-dose, four-period fed human bioequivalence study of eperisone hydrochloride tablets in healthy subjects

主要目的：以上海博悦生物科技有限公司的盐酸乙哌立松片（规格：50mg；生产厂家：华益泰康药业股份有限公司）为受试制剂，以卫材（中国）药业有限公司的盐酸乙哌立松片（商品名：妙纳®，规格：50mg；生产厂家：卫材（中国）药业有限公司）为参比制剂，按生物等效性试验的有关规定，考察两制剂在健康人体内的生物等效性。次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Main purpose: Using Eperisone Hydrochloride Tablets (Specification: 50 mg; Manufacturer: Huayi Taikang Pharmaceutical Co., Ltd.) of Shanghai Boyue Biotechnology Co., Ltd. as the test preparation and Eperisone Hydrochloride Tablets (Trade name: Myona®, Specification: 50 mg; Manufacturer: Eisai (China) Pharmaceutical Co., Ltd.) of Eisai (China) Pharmaceutical Co., Ltd. as the reference preparation, according to the relevant provisions of the bioequivalence test, the bioequivalence of the two preparations in healthy humans was investigated. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date17 Sep 2024

Sponsor / Collaborator

Shanghai Boyue Biotechnology Co., Ltd.

CTR20261632

/ Not yet recruitingNot Applicable

采用单中心、随机、开放、单剂量、两制剂、两周期、两序列交叉设计，分为空腹和餐后给药的人体生物等效性研究

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover design was employed, with human bioequivalence studies conducted on both fasting and postprandial administration.

本试验旨在研究单次空腹和餐后口服福建博悦医药科技有限公司研制、海南皇隆制药股份有限公司生产的苯磺酸美洛加巴林片（5 mg）的药代动力学特征；以DAIICHI SANKYO CO., LTD.持证、TAIYO Pharma Tech CO., LTD., Takatsuki Plan生产的苯磺酸美洛加巴林片（德力静®/Tarlige®，5 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of melogabalin besylate tablets (5 mg) developed by Fujian Boyue Pharmaceutical Technology Co., Ltd. and manufactured by Hainan Huanglong Pharmaceutical Co., Ltd., after a single fasting and postprandial oral administration. Melogabalin besylate tablets (Tarlige®, 5 mg), licensed by DAIICHI SANKYO CO., LTD. and manufactured by TAIYO Pharma Tech CO., LTD., Takatsuki Plan, were used as a reference formulation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two formulations were compared to evaluate their bioequivalence in humans.

Start Date-

Sponsor / Collaborator

Fujian Boyue Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Shanghai Boyue Biotechnology Co., Ltd.

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0 Patents (Medical) associated with Shanghai Boyue Biotechnology Co., Ltd.

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100 Deals associated with Shanghai Boyue Biotechnology Co., Ltd.

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100 Translational Medicine associated with Shanghai Boyue Biotechnology Co., Ltd.

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Pipeline

Pipeline Snapshot as of 13 Jun 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

Discovery

2

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