Delving into the Latest Updates on Shanghai Puyi Chemical Co. Ltd. with Synapse

Overview

Basic Info

Introduction

Shanghai Puyi Chemical Co. Ltd. was established in March 2008, with the legal representative being Que Limin. The company's business scope includes research and development, technology transfer in the fields of chemical and biological industries; sales of chemical raw materials and products (except dangerous goods); business information consulting, enterprise management consulting; and engaging in the import and export business of goods and technologies. In addition, Shanghai Puyi Chemical Technology Co., Ltd. was rated as a technology-based small and medium-sized enterprise, high-tech enterprise, and small and micro enterprise in 2023.

1.评价倍赛诺他片联合伊沙佐米和地塞米松在复发或难治性多发性骨髓瘤患者中的安全性和耐受性；探索剂量限制性毒性（DLT）和最大耐受剂量（MTD）；确定Ⅱ期推荐给药剂量（RP2D），为后续的临床研究提供依据。 2.评价倍赛诺他片联合伊沙佐米和地塞米松在复发或难治性多发性骨髓瘤患者中有效性，以及倍赛诺他和代谢物M1及伊沙佐米的药代动力学（PK）特征。 3.评价倍赛诺他片联合伊沙佐米和地塞米松治疗复发或难治性多发性骨髓瘤患者时的药效动力学（PD）特征，以及微小残留病（MRD）。

[Translation]

1. Evaluate the safety and tolerability of Besanostat tablets combined with ixazomib and dexamethasone in patients with relapsed or refractory multiple myeloma; explore the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD); determine the recommended dose (RP2D) for phase II to provide a basis for subsequent clinical studies. 2. Evaluate the efficacy of Besanostat tablets combined with ixazomib and dexamethasone in patients with relapsed or refractory multiple myeloma, as well as the pharmacokinetic (PK) characteristics of Besanostat and metabolites M1 and ixazomib. 3. Evaluate the pharmacodynamic (PD) characteristics of Besanostat tablets combined with ixazomib and dexamethasone in the treatment of patients with relapsed or refractory multiple myeloma, as well as minimal residual disease (MRD).

Start Date03 Feb 2023

Sponsor / Collaborator

Shanghai Puyi Chemical Co. Ltd.

[+1]

CTR20180269 / CompletedPhase 1

倍赛诺他片在难治性或复发性多发性骨髓瘤患者中的耐受性、药代动力学及初步疗效评价

[Translation] Evaluation of the tolerability, pharmacokinetics and preliminary efficacy of Besanostat tablets in patients with refractory or relapsed multiple myeloma

1.观察倍赛诺他片的人体耐受性及安全性，确定剂量限制性毒性(DLT)及最大耐受剂量（MTD），为II期临床试验制定安全有效的给药方案提供依据； 2.初步考察倍赛诺他片在人体的单次给药、多次给药的药代动力学（PK）； 3.初步评价倍赛诺他片治疗多发性骨髓瘤的疗效。

[Translation]

1. To observe the human tolerability and safety of Besanostat tablets, determine the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD), and provide a basis for formulating a safe and effective dosing regimen for Phase II clinical trials; 2. To preliminarily investigate the pharmacokinetics (PK) of Besanostat tablets in humans after single and multiple doses; 3. To preliminarily evaluate the efficacy of Besanostat tablets in the treatment of multiple myeloma.

Start Date20 Apr 2018

Sponsor / Collaborator

Shanghai Puyi Chemical Co. Ltd.

[+1]

100 Clinical Results associated with Shanghai Puyi Chemical Co. Ltd.

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0 Patents (Medical) associated with Shanghai Puyi Chemical Co. Ltd.

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100 Deals associated with Shanghai Puyi Chemical Co. Ltd.

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100 Translational Medicine associated with Shanghai Puyi Chemical Co. Ltd.

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Pipeline

Pipeline Snapshot as of 26 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

Other

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