Delving into the Latest Updates on UBI Pharma Inc. with Synapse

Overview

Tags

Urogenital Diseases

Hemic and Lymphatic Diseases

Infectious Diseases

Small molecule drug

Cytokines

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

Hemic and Lymphatic Diseases	4
Infectious Diseases	3
Neoplasms	3
Endocrinology and Metabolic Disease	2
Immune System Diseases	2
Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	3
Cytokines	2
Inactivated vaccine	1
Biosimilar	1
Fusion protein	1

Top 5 Target	Count

BRAF(Serine/threonine-protein kinase B-raf)	1
EPO receptor(Erythropoietin receptor)	1
factor IX(Coagulation factor IX)	1
Globo H	1
CD4(T-cell surface antigen CD4)	1

主要目的确定研究人群中adagloxad simolenin (OBI-822)/OBI-821治疗对IDFS改善的影响。次要目的研究的次要目的是： 1. 确定研究人群中adagloxad simolenin (OBI-822)/OBI-821治疗对以下方面的影响： a. 总生存期（OS） b. 生活质量（QoL） c. 无乳腺癌间期（BCFI） d. 无远处转移间期（DDFS） 2. 确定研究人群中adagloxad simolenin (OBI-822)/OBI-821的安全性和耐受性。探索性目的探索性目的如下： 1. 探索adagloxad simolenin （OBI-822）/OBI-821抗Globo H抗体应答、IDFS以及OS之间的相关性 2. 评价Globo H肿瘤表达对IDFS和OS的影响 3. 识别可预测adagloxad simolenin（OBI-822）/OBI-821治疗结局的患者基线特征和人口统计学特征 4. 探索基线特征（包括肿瘤病理、分子和免疫特征）和肿瘤表达水平之间的相关性

[Translation]

Primary Objective To determine the effect of adagloxad simolenin (OBI-822)/OBI-821 treatment on improvement of IDFS in the study population. Secondary Objectives The secondary objectives of the study are: 1. To determine the effect of adagloxad simolenin (OBI-822)/OBI-821 treatment on the following aspects in the study population: a. Overall survival (OS) b. Quality of life (QoL) c. Breast cancer free interval (BCFI) d. Distant metastasis free interval (DDFS) 2. To determine the safety and tolerability of adagloxad simolenin (OBI-822)/OBI-821 in the study population. Exploratory objectives The exploratory objectives are as follows: 1. To explore the correlation between adagloxad simolenin (OBI-822)/OBI-821 anti-Globo H antibody response, IDFS, and OS 2. To evaluate the impact of Globo H tumor expression on IDFS and OS 3. To identify patient baseline and demographic characteristics that may predict adagloxad simolenin (OBI-822)/OBI-821 treatment outcomes 4. To explore the correlation between baseline characteristics (including tumor pathology, molecular and immune characteristics) and tumor expression levels

Start Date07 Dec 2021

Sponsor / Collaborator

Zuellig Pharma China

[+3]

CTR20210376 / Active, not recruitingPhase 3

评价塞纳布啡长效注射液缓解术后疼痛有效性和安全性的随机、双盲、安慰剂平行对照多中心临床试验

[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy and safety of senabuphine long-acting injection in relieving postoperative pain

比较塞纳布啡长效注射液组与安慰剂组术后48小时内吗啡总用量，以评价塞纳布啡长效注射液缓解术后疼痛的有效性。评价塞纳布啡长效注射液缓解术后疼痛的安全性。

[Translation]

To compare the total amount of morphine used within 48 hours after surgery between the senabuphine long-acting injection group and the placebo group to evaluate the effectiveness of senabuphine long-acting injection in relieving postoperative pain. To evaluate the safety of senabuphine long-acting injection in relieving postoperative pain.

Start Date04 Jun 2021

Sponsor / Collaborator

Lumosa Therapeutics Co., Ltd.

[+2]

NCT02708914 / CompletedPhase 3

A Phase III Trial to Compare the Safety and Efficacy of Intravenous UB-851 and Eprex® With an Extension Safety Evaluation in Subjects With Renal Anemia on Hemodialysis

The primary objective of this study is to evaluate a 1:1 dose conversion from Eprex® to UB-851 in terms of clinical efficacy and safety in subjects with chronic renal failure receiving hemodialysis.

Start Date01 Mar 2016

Sponsor / Collaborator

UBI Pharma Inc.

100 Clinical Results associated with UBI Pharma Inc.

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0 Patents (Medical) associated with UBI Pharma Inc.

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1

Literatures (Medical) associated with UBI Pharma Inc.

01 Apr 2018·Journal of Food and Drug AnalysisQ2 · MEDICINE

Risk undermined in the bilateral pharmaceutical regulatory system in Taiwan

Q2 · MEDICINE

ReviewOA

Author: Wang, Chun-Li ; Wang, Hui-Po

The concept of Pharmacovigilance Planning and Risk Minimization Planning (PVP/RMP), initiated by the International Conference on Harmonization (ICH), addressed an important conceptual change from monitoring the safety of individual medicine to proactively conducting risk prevention for the minimization of medication error. However, the implementation of PVP/RMP is a challenge in societies like Taiwan where irrational medication and co-medication is prevalent. It is even more difficult in Taiwan where two regulatory bodies are governing pharmaceutical affairs, namely Taiwan Food and Drug Administration (TFDA) in charge of Western Medicine (WM) and the Department of Chinese Medicine and Pharmacy (DCMP) in charge of Traditional Chinese Medicine (TCM). There are thus dual-tract drug approval panels, two GMP controls and two independent adverse drug event reporting systems. This rendered irrational co-medication of WM and TCM undetectable and the standard tools for monitoring pharmacovigilance inapplicable. The bilateral regulatory system is conceptually unscientific in accordance with PVP/RMP and unethical from humanity point of view. The first part of this review delivers (1) social aspects of polypharmacy in Taiwan; (2) regulatory aspects of pharmaceutical administration; (3) risks undermined in the bilateral regulatory system and (4) pharmacoepidemiology in relation to the risk of polypharmacy. As evidence-based medicine (EBM) forms the fundamental risk-benefit assessment on medication, the second part of this review delivers (1) the scientific aspects of the beauty and the odds of biological system that governs host-xenobiotics interaction; (2) conceptual evolution from product management (pharmacovigilance) to risk management (PVP/RMP); (3) non-biased due process is essential for risk-benefit assessment on medicinal products and (4) the opinion of the authors on system building for safe medication.

100 Deals associated with UBI Pharma Inc.

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100 Translational Medicine associated with UBI Pharma Inc.

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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

Discovery

1

2

Preclinical

IND Application

1

Phase 1 Clinical

Phase 3 Clinical

4

1

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Semzuvolimab ( CD4 )	HIV Infections More	Phase 3
Dinalbuphine sebacate ( κ opioid receptor x μ opioid receptor )	Moderate pain More	Phase 3
Adagloxad simolenin ( Globo H )	Triple Negative Breast Cancer More	Phase 3
Epoetin alfa biosimilar(United Biomedical, Inc.) ( EPO receptor )	-	Phase 3
UB-852	Anemia More	Phase 1