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

Overview

Tags

Endocrinology and Metabolic Disease

Nervous System Diseases

Eye Diseases

Recombinant polypeptide

Fusion protein

Synthetic peptide

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	2
Infectious Diseases	1
Nervous System Diseases	1

Top 5 Drug Type	Count

Recombinant polypeptide	2
Synthetic peptide	1
Biosimilar	1
Fusion protein	1
Chemical drugs	1

Top 5 Target	Count

GIPR x GLP-1R	1
PTH1R(Parathyroid hormone receptor)	1
FANCB(FA complementation group B)	1

主要目的：研究中国健康受试者单次和多次肌肉给予注射用重组促皮质素后的安全性和耐受性，确定安全剂量的范围。次要目的： 1. 研究中国健康受试者单次和多次肌肉给予注射用重组促皮质素后活性成分 rACTH 的药代动力学（Pharmacokinetics，PK）特征。 2. 研究中国健康受试者单次和多次肌肉给予注射用重组促皮质素后的药效学（Pharmacodynamics, PD）特征。

[Translation]

Primary objective: To study the safety and tolerability of single and multiple intramuscular administration of recombinant corticotropin for injection in healthy Chinese subjects and to determine the safe dose range. Secondary objectives: 1. To study the pharmacokinetic (PK) characteristics of the active ingredient rACTH after single and multiple intramuscular administration of recombinant corticotropin for injection in healthy Chinese subjects. 2. To study the pharmacodynamic (PD) characteristics of recombinant corticotropin for injection in healthy Chinese subjects after single and multiple intramuscular administration.

Start Date-

Sponsor / Collaborator

Shanghai Duomirui Biotechnology Co., Ltd.

CTR20242163 / SuspendedPhase 1

注射用人高血糖素与诺和生®皮下注射给药在中国健康受试者中的单中心、随机、开放、四周期、重复交叉、单次给药的药代动力学、药效动力学及安全性的比对研究

[Translation] A single-center, randomized, open-label, four-period, repeated crossover, single-dose comparative study of the pharmacokinetics, pharmacodynamics, and safety of human glucagon for injection versus Novazoma® for subcutaneous injection in healthy Chinese subjects

主要目的 1.评价与对照组诺和生®相比，受试者单次皮下注射注射用人高血糖素后，高血糖素药代动力学较基线的变化。次要目的 1.评价与对照组诺和生®相比，受试者单次皮下注射注射用人高血糖素后，高血糖素药效动力学较基线的变化。 2.评价与阳性对照组诺和生®相比，单次皮下注射注射用人高血糖素在中国健康受试者中的安全性。

[Translation]

Main purpose 1. To evaluate the changes in the pharmacokinetics of glucagon compared with baseline after a single subcutaneous injection of human glucagon in subjects compared with the control group, Novosun®. Secondary purpose 1. To evaluate the changes in the pharmacodynamics of glucagon compared with baseline after a single subcutaneous injection of human glucagon in subjects compared with the control group, Novosun®. 2. To evaluate the safety of a single subcutaneous injection of human glucagon in Chinese healthy subjects compared with the positive control group, Novosun®.

Start Date19 Aug 2024

Sponsor / Collaborator

Shanghai Duomirui Biotechnology Co., Ltd.

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

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

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2

Literatures (Medical) associated with Shanghai Duomirui Biotechnology Co., Ltd.

15 May 2024·Bioconjugate Chemistry

Design and Biological Evaluation of the Long-Acting C5-Inhibited Ornithodoros moubata Complement Inhibitor (OmCI) Modified with Fatty Acid

Article

Author: Wang, Yandan ; Feng, Meiqing ; Shangguan, Wenwen ; Li, Xiaowan ; Feng, Jun ; Dong, Yuanzhen ; Huang, Zongqing

Disorder of complement response is a significant pathogenic factor causing some autoimmune and inflammation diseases. The Ornithodoros moubata Complement Inhibitor (OmCI), a small 17 kDa natural protein, was initially extracted from soft tick salivary glands. The protein was found binding to complement C5 specifically, inhibiting the activation of the complement pathway, which is a successful therapeutic basis of complement-mediated diseases. However, a short half-life due to rapid renal clearance is a common limitation of small proteins for clinical application. In this study, we extended the half-life of OmCI by modifying it with fatty acid, which was a method used to improve the pharmacokinetics of native peptides and proteins. Five OmCI mutants were initially designed, and single-site cysteine mutation was introduced to each of them. After purification, four OmCI mutants were obtained that showed similar in vitro biological activities. Three mutants of them were subsequently coupled with different fatty acids by nucleophilic substitution. In total, 15 modified derivatives were screened and tested for anticomplement activity in vitro. The results showed that coupling with fatty acid would not significantly affect their complement-inhibitory activity (CH50 and AH50). OmCIT90C-CM02 and OmCIT90C-CM05 were validated as the applicable OmCI bioconjugates for further pharmacokinetic assessments, and both showed improved plasma half-life in mice compared with unmodified OmCI (15.86, 17.96 vs 2.57 h). In summary, our data demonstrated that OmCI conjugated with fatty acid could be developed as the potential long-acting C5 complement inhibitor in the clinic.

01 Aug 2021·European Journal of PharmacologyQ3 · MEDICINE

Design and biological evaluation of novel long-acting adalimumab Fab conjugated with the albumin binding domain

Q3 · MEDICINE

Article

Author: Zhang, Qingbin ; Wang, Yapeng ; Lu, Jianguang ; Feng, Jun ; Shangguan, Wenwen ; Qian, Mengxin ; Zhao, Wenjie ; Wu, Yong

Antigen-binding fragments (Fabs) are preferred alternatives to antibodies for medical application, whereas their short half-lives limit therapeutic effectiveness. Albumin binding domain (ABD) with high affinity for albumin possesses a great potential in enhancing in vivo performance of biotherapeutics. In this study, to mitigate the poor pharmacokinetics of adalimumab Fab targeting tumor necrosis factor-α (TNFα), an ABD fusion strategy was applied innovatively using GA3, ABD035, ABD094 and ABDCon with high affinities for albumin. The prokaryotic expression, bioactivities and half-lives of those novel Fab-ABD fusions were investigated in vitro and in vivo. All Fab-ABD fusions were successfully purified, and they retained similar TNFα-binding activities with the unmodified Fab control, also presented high affinities for human/mouse serum albumin (HSA/MSA). Additionally, the simultaneous binding of the difunctional Fab-ABD fusions to TNFα and albumin was verified, and ABD fused to Fab neither interfered with Fab-TNFα binding nor impaired the association between Fc fragment of IgG receptor and transporter (FcRn) and albumin. Based on the highest binding affinity for HSA and maximal yield, Fab-ABDCon was selected for further evaluation. Fab-ABDCon showed similar thermostability with the Fab control and robust stability in human and mouse plasma. Most notably, the pharmacokinetics of Fab-ABDCon in mice was significantly improved with a 22-fold longer plasma half-life (28.2 h) compared with that of Fab control (1.31 h), which have contributed to its satisfactory therapeutic efficacy in murine TNFα-induced hepatonecrosis model. Thus, Fab-ABDCon could be a promising long-acting candidate suitable for drug development targeting TNFα-mediated inflammatory disease.

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

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

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Pipeline

Pipeline Snapshot as of 07 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

Discovery

2

1

Preclinical

IND Approval

1

Phase 1 Clinical

Other

1

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Recombinant corticotropin (Shanghai Duomirui Biotech)	Spasm More	Phase 1
Recombinant Teriparatide(Duomirui Biotech) ( PTH1R )	Osteoporosis, Postmenopausal More	IND Approval
D-314 ( GIPR x GLP-1R )	Diabetes Mellitus, Type 2 More	Preclinical
CN114621354 ( FANCB )	Uveal Diseases More	Discovery
DMR-HRP-106	infectious disease resistant to multiple drugs More	Discovery