Delving into the Latest Updates on CMIC CMO Co., Ltd. with Synapse

Overview

Tags

Skin and Musculoskeletal Diseases

Immune System Diseases

Congenital Disorders

Small molecule drug

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	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

PDE4B(Phosphodiesterase 4B)	1

1、主要目的：以第 4 周的研究者整体评估（IGA）成功率为主要终点，在成人AD受试者中证明接受持续4周每日两次IMP给药（1% OPA15406 软膏）后，1% OPA-15406 软膏优效于赋形剂。 2、次要目的：评价成人AD受试者接受每日两次IMP（1% OPA-15406软膏）持续4周给药的有效性（次要终点）和安全性。评价1% OPA-15406软膏在中国成人AD受试者体内的药代动力学。

[Translation]

1. Primary objective: To demonstrate that 1% OPA-15406 ointment is superior to vehicle in adult AD subjects after receiving IMP (1% OPA15406 ointment) twice daily for 4 weeks, with the Investigator's Global Assessment (IGA) success rate at week 4 as the primary endpoint. 2. Secondary objective: To evaluate the efficacy (secondary endpoint) and safety of adult AD subjects receiving IMP (1% OPA-15406 ointment) twice daily for 4 weeks. To evaluate the pharmacokinetics of 1% OPA-15406 ointment in Chinese adult AD subjects.

Start Date28 Feb 2023

Sponsor / Collaborator

Otsuka Pharmaceutical Co., Ltd.

[+2]

CTR20223249 / RecruitingPhase 3

一项评价0.3%和1% OPA-15406软膏在特应性皮炎儿童受试者中与赋形剂对比证明优效性的多中心，随机，双盲，赋形剂平行对照临床试验

[Translation] A multicenter, randomized, double-blind, vehicle-controlled clinical trial evaluating 0.3% and 1% OPA-15406 ointment to demonstrate superiority compared to vehicle in pediatric subjects with atopic dermatitis

1、主要目的：以第4周的研究者整体评估（IGA）成功率为主要终点，证明儿童AD受试者在接受每日两次IMP给药（0.3%和1% OPA-15406软膏），持续4周治疗时，0.3%和1% OPA-15406软膏优效于赋形剂。 2、次要目的：以评价儿童AD受试者接受持续4周、每日两次0.3%和1% OPA-15406软膏给药的有效性和安全性为次要终点。

[Translation]

1. Primary objective: The primary endpoint is the investigator global assessment (IGA) success rate at week 4, to prove that 0.3% and 1% OPA-15406 ointment is superior to the vehicle when pediatric AD subjects receive IMP twice daily (0.3% and 1% OPA-15406 ointment) for 4 weeks. 2. Secondary objective: The secondary endpoint is to evaluate the efficacy and safety of 0.3% and 1% OPA-15406 ointment twice daily for 4 weeks in pediatric AD subjects.

Start Date15 Feb 2023

Sponsor / Collaborator

Otsuka Pharmaceutical Co., Ltd.

[+2]

CTR20130121 / CompletedPhase 1

西他沙星（DU-6859a）片在中国健康受试者中的药代动力学研究

[Translation] Pharmacokinetic study of sitafloxacin (DU-6859a) tablets in healthy Chinese subjects

评价健康受试者单次空腹口服西他沙星50mg、100mg、200mg后的药代动力学及安全性。评价健康受试者多次口服西他沙星100mg每日2次后的药代动力学及安全性。

[Translation]

To evaluate the pharmacokinetics and safety of sitafloxacin 50mg, 100mg, and 200mg in healthy subjects after single oral administration on an empty stomach. To evaluate the pharmacokinetics and safety of sitafloxacin 100mg twice daily in healthy subjects after multiple oral administration.

Start Date06 Jul 2013

Sponsor / Collaborator

Daiichi Sankyo Co., Ltd.

[+1]

100 Clinical Results associated with CMIC CMO Co., Ltd.

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0 Patents (Medical) associated with CMIC CMO Co., Ltd.

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3

Literatures (Medical) associated with CMIC CMO Co., Ltd.

Pharm Tech Japan

A new future for orally disintegrating tablets developed by 3D printing technology

Author: Yamada, Maraki ; Wetherhold, Don ; Otoda, Kazuya ; Iwata, Motokazu

Pharm Tech Japan

Optimization study for wet granulation processing speed 3. case study of DOME-EX

Author: Yamada, Masaki ; Asai, Naochika

Pharm Tech Japan

Design of orally disintegrating tablet by heat treatment or external lubrication process

Author: Iwata, Motokazu

Orally disintegrating tablet (OD tablet) is a dosage form which can be swallowed without water.Recent progress in formulation and manufacturing technologies enabled 01) tablet with conflicting properties. fast disintegration and sufficient strength (hardness).Examples of such OD tablets processed by two different concepts are introduced.The tablet with amorphous state binder and controlled moisture content, prepared at lower compression pressure followed by heat treatment, exhibited fast disintegrating property due to higher porosity.External lubrication tablet with increased hardness demonstrated fast disintegrating property based on increased hygroscopicity (accelerated water penetration).

100 Deals associated with CMIC CMO Co., Ltd.

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100 Translational Medicine associated with CMIC CMO Co., Ltd.

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Pipeline

Pipeline Snapshot as of 25 Dec 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

Phase 3

1

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Difamilast ( PDE4B )	Dermatitis, Atopic More	Phase 3
Sitafloxacin Hydrate ( Bacterial DNA gyrase x Topoisomerase IV )	Complicated urinary tract infection More	Pending