Delving into the Latest Updates on Shanghai Taiyin Biological Engineering Co., Ltd. with Synapse

Overview

Tags

Immune System Diseases

Respiratory Diseases

Hemic and Lymphatic Diseases

Monoclonal antibody

Biosimilar

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	2
Hemic and Lymphatic Diseases	1
Neoplasms	1

Top 5 Drug Type	Count

Monoclonal antibody	2
Biosimilar	1

Top 5 Target	Count

CD52(CAMPATH-1 antigen)	1
IgE(Immunoglobulin E)	1

多中心、单臂、开放、非随机化评价重组人源化抗CD52 单克隆抗体注射液治疗复发难治的 NHL（包括CLL/SLL、 PLL、 PTCL、弥漫大 B 细胞淋巴瘤、滤泡细胞淋巴瘤、套细胞淋巴瘤、边缘区淋巴瘤）、初治的 T-PLL 安全及耐受性、药代动力学特征并初步探索疗效的Ⅰ期临床研究。

[Translation] This is a multicenter, single-arm, open, non-randomized Phase I clinical study to evaluate the safety and tolerability, pharmacokinetic characteristics, and preliminary efficacy of recombinant humanized anti-CD52 monoclonal antibody injection in the treatment of relapsed or refractory NHL (including CLL/SLL, PLL, PTCL, diffuse large B-cell lymphoma, follicular cell lymphoma, mantle cell lymphoma, marginal zone lymphoma) and newly diagnosed T-PLL.

主要研究目的是评价单次、多次不同剂量重组人源化抗 CD52 单克隆抗体注射液在患者体内的安全性及耐受性，并确定剂量限制性毒性（DLT）和最大耐受剂量（MTD），为Ⅱ期推荐剂量（RP2D）。次要研究目的是评价单次、多次不同剂量重组人源化抗 CD52 单克隆抗体注射液在患者体内的药代动力学（PK）特征并初步探索疗效。

[Translation]

The primary study objective is to evaluate the safety and tolerability of single and multiple doses of recombinant humanized anti-CD52 monoclonal antibody injection in patients, and to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), which is the recommended dose for Phase II (RP2D). The secondary study objective is to evaluate the pharmacokinetic (PK) characteristics of single and multiple doses of recombinant humanized anti-CD52 monoclonal antibody injection in patients and to preliminarily explore the efficacy.

Start Date25 Nov 2020

Sponsor / Collaborator

Shanghai Taiyin Biological Engineering Co., Ltd.

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100 Clinical Results associated with Shanghai Taiyin Biological Engineering Co., Ltd.

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0 Patents (Medical) associated with Shanghai Taiyin Biological Engineering Co., Ltd.

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100 Deals associated with Shanghai Taiyin Biological Engineering Co., Ltd.

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100 Translational Medicine associated with Shanghai Taiyin Biological Engineering Co., Ltd.

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Pipeline

Pipeline Snapshot as of 22 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

Preclinical

1

Phase 1 Clinical

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Recombinant anti-CD52 humanized monoclonal antibody(Lanzhou Institute of Biological Products Co. Ltd.) ( CD52 )	B-Cell Prolymphocytic Leukemia More	Phase 1
Omalizumab Biosimilar (Shanghai Taiyin Biotech) ( IgE )	Asthma More	Preclinical