Delving into the Latest Updates on Shanghai Biomabs Pharmaceuticals Co., Ltd. with Synapse

Overview

Basic Info

Introduction

Shanghai Biomabs Pharmaceutical Co., Ltd., established in October 2009, focuses on the development, technology transfer, manufacturing, and commercialization of biopharmaceuticals, primarily monoclonal antibody therapeutics. It is among the pioneer biopharmaceutical enterprises in China to delve into the realm of antibody-based drugs and has secured numerous patents and proprietary technologies for innovative antibody medicines both domestically and internationally.

Tags

Congenital Disorders

Endocrinology and Metabolic Disease

Eye Diseases

Biosimilar

Monoclonal antibody

Fab fragment

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

Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Biosimilar	2
Monoclonal antibody	1
Fab fragment	1

Top 5 Target	Count

VEGF-A(Vascular endothelial growth factor A)	1
RANKL(Tumor necrosis factor ligand superfamily member 11)	1

主要目的：比较生产场地变更后的 CMAB807 注射液与普罗力®在中国成年男性健康受试者的药代动力学特征相似性。次要目的：比较生产场地变更后的 CMAB807 注射液与普罗力®在中国成年男性健康受试者的安全性、药效学和免疫原性相似性。

[Translation]

Primary objective: Compare the pharmacokinetic characteristics of CMAB807 injection after the change of production site and Proli® in Chinese adult male healthy subjects. Secondary objective: Compare the safety, pharmacodynamics and immunogenicity of CMAB807 injection after the change of production site and Proli® in Chinese adult male healthy subjects.

Start Date02 Nov 2023

Sponsor / Collaborator

Shanghai MabLab Biotechnology Co., Ltd.

[+1]

CTR20211034 / Active, not recruitingPhase 1

一项随机、双盲、平行对照，比较CMAB818 注射液与诺适得®在湿性年龄相关性黄斑变性患者的安全性、免疫原性、药代动力学、药效学和初步疗效的I 期研究。

[Translation] A randomized, double-blind, parallel-controlled Phase I study comparing the safety, immunogenicity, pharmacokinetics, pharmacodynamics and preliminary efficacy of CMAB818 injection with Lusitanicotinamide® in patients with wet age-related macular degeneration.

主要目的：评价CMAB818 注射液和诺适得®在wAMD 患者目标眼单次（0.5 mg）玻璃体内注射的安全性；次要目的：评价CMAB818 注射液和诺适得®在wAMD 患者目标眼单次（0.5 mg）玻璃体内注射的免疫原性、药代动力学特征和药效学特征；评价CMAB818 注射液和诺适得®在wAMD 患者目标眼单次（0.5 mg）玻璃体内注射的临床初步疗效。

[Translation]

Primary objective: To evaluate the safety of a single (0.5 mg) intravitreal injection of CMAB818 injection and Lucentis® in the target eye of wAMD patients; Secondary objective: To evaluate the immunogenicity, pharmacokinetic characteristics and pharmacodynamic characteristics of a single (0.5 mg) intravitreal injection of CMAB818 injection and Lucentis® in the target eye of wAMD patients; To evaluate the preliminary clinical efficacy of a single (0.5 mg) intravitreal injection of CMAB818 injection and Lucentis® in the target eye of wAMD patients.

Start Date03 Jun 2021

Sponsor / Collaborator

Shanghai Biomabs Pharmaceuticals Co., Ltd.

NCT04884399 / CompletedPhase 1

A Randomized, Double-blind, Two-group Parallel, Positive-controlled Clinical Phase I Trial Comparing the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of CMAB818 and Lucentis® in Patients With Wet Age-related Macular Degeneration.

This is a randomized, double-blind, two-group parallel, positive-controlled clinical Phase I trial comparing the safety, pharmacokinetics, pharmacodynamics and efficacy of CMAB818 and Lucentis® in patients with wet age-related macular degeneration.

Start Date03 Jun 2021

Sponsor / Collaborator

Shanghai Biomabs Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Shanghai Biomabs Pharmaceuticals Co., Ltd.

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0 Patents (Medical) associated with Shanghai Biomabs Pharmaceuticals Co., Ltd.

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1

Literatures (Medical) associated with Shanghai Biomabs Pharmaceuticals Co., Ltd.

03 Oct 2015·AutophagyQ1 · BIOLOGY

Elaiophylin, a novel autophagy inhibitor, exerts antitumor activity as a single agent in ovarian cancer cells

Q1 · BIOLOGY

Article

Author: Zheng, Zhihui ; Ma, Ding ; Zhou, Jianfeng ; Qin, Yu ; Zhao, Xuejiao ; Wang, Ting ; Wang, Daowen ; Yang, Yang ; Fang, Yong ; Lu, Xinhua ; Lai, Huiling ; Zhang, Hua ; Meng, Li ; Gao, Qinglei ; Wu, Peng

Currently, targeting the autophagic pathway is regarded as a promising new strategy for cancer drug discovery. Here, we screened the North China Pharmaceutical Group Corporation's pure compound library of microbial origin using GFP-LC3B-SKOV3 cells and identified elaiophylin as a novel autophagy inhibitor. Elaiophylin promotes autophagosome accumulation but blocks autophagic flux by attenuating lysosomal cathepsin activity, resulting in the accumulation of SQSTM1/p62 in various cell lines. Moreover, elaiophylin destabilizes lysosomes as indicated by LysoTracker Red staining and CTSB/cathepsin B and CTSD/ cathepsin D release from lysosomes into the cytoplasm. Elaiophylin eventually decreases cell viability, especially in combination with cisplatin or under hypoxic conditions. Furthermore, administration of a lower dose (2 mg/kg) of elaiophylin as a single agent achieves a significant antitumor effect without toxicity in an orthotopic ovarian cancer model with metastasis; however, high doses (8 mg/kg) of elaiophylin lead to dysfunction of Paneth cells, which resembles the intestinal phenotype of ATG16L1-deficient mice. Together, these results provide a safe therapeutic window for potential clinical applications of this compound. Our results demonstrate, for the first time, that elaiophylin is a novel autophagy inhibitor, with significant antitumor efficacy as a single agent or in combination in human ovarian cancer cells, establishing the potential treatment of ovarian cancer by this compound.

100 Deals associated with Shanghai Biomabs Pharmaceuticals Co., Ltd.

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100 Translational Medicine associated with Shanghai Biomabs Pharmaceuticals Co., Ltd.

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Pipeline

Pipeline Snapshot as of 08 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 Approval

1

Phase 1 Clinical

Phase 3 Clinical

1

3

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Denosumab Biosimilar (Biomabs Pharma) ( RANKL )	Fractures, Bone More	Phase 3
Ranibizumab biosimilar (Shanghai Biomabs) ( VEGF-A )	Wet Macular Degeneration More	Phase 1
CMAB-807X ( RANKL )	Bone metastases More	IND Approval
Anakinra biosimilar(Shanghai Biomabs Pharmaceuticals Co., Ltd.) ( IL1R1 )	Rheumatoid Arthritis More	Pending
Adalimumab biosimilar(Biomabs) ( TNF-α )	Rheumatoid Arthritis More	Pending