Delving into the Latest Updates on Zhuhai Resproly Biopharmaceutical Co., Ltd. with Synapse

Overview

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Small molecule drug

Disease domain score

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Technology Platform

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Targets

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Disease Domain	Count

Immune System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

GR x β2-adrenergic receptor	1

主要目的：评估中国健康受试者在空腹条件下经口吸入受试制剂布地奈德福莫特罗吸入粉雾剂（Ⅱ）（珠海瑞思普利医药科技有限公司生产，规格：160 μg/4.5 μg）和参比制剂布地奈德福莫特罗吸入粉雾剂（Ⅱ）（AstraZeneca AB 生产，商品名：信必可都保®/Symbicort Turbuhaler®，规格：160 μg/4.5 μg）的药代动力学行为，评价两者在健康受试者体内的生物等效性。次要目的：评价中国健康受试者在空腹条件下经口吸入受试制剂和参比制剂的安全性。

[Translation]

Primary objective: To evaluate the pharmacokinetic behavior of the test preparation budesonide formoterol inhalation powder (II) (produced by Zhuhai Ruisipuli Pharmaceutical Technology Co., Ltd., specifications: 160 μg/4.5 μg) and the reference preparation budesonide formoterol inhalation powder (II) (produced by AstraZeneca AB, trade name: Symbicort Turbuhaler®/Symbicort Turbuhaler®, specifications: 160 μg/4.5 μg) in healthy Chinese subjects under fasting conditions, and to evaluate the bioequivalence of the two in healthy subjects. Secondary objective: To evaluate the safety of the test preparation and the reference preparation in Chinese healthy subjects under fasting conditions.

Start Date-

Sponsor / Collaborator

Zhuhai Resproly Biopharmaceutical Co., Ltd.

CTR20253171

/ Not yet recruitingNot Applicable

单中心、随机、开放、单剂量、两序列、两周期交叉设计评价中国健康受试者单次空腹经口吸入布地奈德福莫特罗吸入粉雾剂（Ⅱ）的生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-sequence, two-period crossover design study to evaluate the bioequivalence of a single oral inhalation of budesonide and formoterol inhalation powder (II) in Chinese healthy volunteers on an empty stomach

主要目的：评估中国健康受试者在空腹条件下经口吸入受试制剂布地奈德福莫特罗吸入粉雾剂（Ⅱ）（珠海瑞思普利医药科技有限公司）和参比制剂布地奈德福莫特罗吸入粉雾剂（Ⅱ）（AstraZeneca AB，商品名：信必可都保®/Symbicort Turbuhaler®）的药代动力学行为，评价两者在健康受试者体内的生物等效性。次要目的：评价中国健康受试者在空腹条件下经口吸入受试制剂和参比制剂的安全性。

[Translation]

Primary objective: To evaluate the pharmacokinetic behavior of the test formulation, budesonide and formoterol inhalation powder (II) (Zhuhai Ruisi Puli Pharmaceutical Technology Co., Ltd.) and the reference formulation, budesonide and formoterol inhalation powder (II) (AstraZeneca AB, trade name: Symbicort Turbuhaler®) in healthy Chinese volunteers after oral inhalation under fasting conditions, and to assess their bioequivalence in healthy subjects. Secondary objective: To evaluate the safety of the test formulation and reference formulation after oral inhalation under fasting conditions in healthy Chinese volunteers.

Start Date-

Sponsor / Collaborator

Zhuhai Resproly Biopharmaceutical Co., Ltd.

100 Clinical Results associated with Zhuhai Resproly Biopharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Zhuhai Resproly Biopharmaceutical Co., Ltd.

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100 Deals associated with Zhuhai Resproly Biopharmaceutical Co., Ltd.

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100 Translational Medicine associated with Zhuhai Resproly Biopharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 15 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

IND Application

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