Delving into the Latest Updates on Sinotherapeutics, Inc. with Synapse

Overview

Tags

Immune System Diseases

Respiratory Diseases

Hemic and Lymphatic Diseases

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

Hemic and Lymphatic Diseases	1
Infectious Diseases	1
Immune System Diseases	1
Neoplasms	1

Top 5 Drug Type	Count

Small molecule drug	2

Top 5 Target	Count

PA protein x RdRp	1
PI3Kδ(Phosphatidylinositol 3 kinase delta)	1

主要研究目的：研究餐后状态下单次口服受试制剂多索茶碱片（规格：400mg，江苏宣泰药业有限公司）与参比制剂多索茶碱片（商品名：ANSIMAR®，规格：400mg，ABC FARMACEUTICI S.P.A.）在健康成年受试者体内的药代动力学，评价餐后状态下口服两种制剂的生物等效性。次要研究目的: 评价健康受试者餐后单次口服受试制剂（T）多索茶碱片和参比制剂（R）多索茶碱片（商品名：ANSIMAR®）后的安全性。

[Translation]

Main study objectives: To study the pharmacokinetics of the test preparation Doxofylline Tablets (Specification: 400mg, Jiangsu Xuantai Pharmaceutical Co., Ltd.) and the reference preparation Doxofylline Tablets (Trade name: ANSIMAR®, Specification: 400mg, ABC FARMACEUTICI S.P.A.) in healthy adult subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. Secondary study objectives: To evaluate the safety of the test preparation (T) Doxofylline Tablets and the reference preparation (R) Doxofylline Tablets (Trade name: ANSIMAR®) after a single oral administration in healthy subjects.

Start Date08 Oct 2024

Sponsor / Collaborator

Jiangsu Xuantai Pharmaceutical Co., Ltd

CTR20242953 / RecruitingNot Applicable

评估受试制剂维生素K1片（规格：5 mg）与参比制剂维生素K1片（规格：5 mg）在健康成年参与者餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性试验

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test vitamin K1 tablets (strength: 5 mg) and the reference vitamin K1 tablets (strength: 5 mg) in healthy adult participants in the postprandial state.

主要试验目的：研究餐后状态下单次口服受试制剂维生素K1片（规格：5 mg，江苏宣泰药业有限公司生产）与参比制剂维生素K1片（规格：5 mg；Cadila Healthcare Limited生产）在健康参与者体内的药代动力学特征，评价餐后状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂维生素K1片（规格：5 mg）和参比制剂维生素K1片（规格：5 mg）在健康参与者中的安全性。

[Translation]

Main purpose of the study: To study the pharmacokinetic characteristics of the test vitamin K1 tablet (specification: 5 mg, produced by Jiangsu Xuantai Pharmaceutical Co., Ltd.) and the reference vitamin K1 tablet (specification: 5 mg; produced by Cadila Healthcare Limited) in healthy participants after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. Secondary purpose of the study: To study the safety of the test vitamin K1 tablet (specification: 5 mg) and the reference vitamin K1 tablet (specification: 5 mg) in healthy participants.

Start Date04 Sep 2024

Sponsor / Collaborator

Sinotherapeutics, Inc.

CTR20242952 / RecruitingNot Applicable

评估受试制剂维生素K1片（规格：5 mg）与参比制剂维生素K1片（规格：5 mg）在健康成年参与者空腹状态下的单中心、开放、随机、单剂量、四周期、两序列、完全重复交叉生物等效性试验

[Translation] A single-center, open-label, randomized, single-dose, four-period, two-sequence, fully repeated crossover bioequivalence study to evaluate the bioequivalence of the test vitamin K1 tablets (strength: 5 mg) and the reference vitamin K1 tablets (strength: 5 mg) in healthy adult participants under fasting conditions.

主要试验目的：研究空腹状态下单次口服受试制剂维生素K1片（规格：5 mg，江苏宣泰药业有限公司生产）与参比制剂维生素K1片（规格：5 mg；Cadila Healthcare Limited生产）在健康参与者体内的药代动力学特征，评价空腹状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂维生素K1片（规格：5 mg）和参比制剂维生素K1片（规格：5 mg）在健康参与者中的安全性。

[Translation]

Main purpose of the study: To study the pharmacokinetic characteristics of a single oral dose of the test vitamin K1 tablet (specification: 5 mg, produced by Jiangsu Xuantai Pharmaceutical Co., Ltd.) and the reference vitamin K1 tablet (specification: 5 mg; produced by Cadila Healthcare Limited) in healthy participants under fasting conditions, and to evaluate the bioequivalence of the two oral preparations under fasting conditions. Secondary purpose of the study: To study the safety of the test vitamin K1 tablet (specification: 5 mg) and the reference vitamin K1 tablet (specification: 5 mg) in healthy participants.

Start Date01 Sep 2024

Sponsor / Collaborator

Sinotherapeutics, Inc.

100 Clinical Results associated with Sinotherapeutics, Inc.

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0 Patents (Medical) associated with Sinotherapeutics, Inc.

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1

Literatures (Medical) associated with Sinotherapeutics, Inc.

01 Jan 2019·Chinese Journal of Chromatography

Impurity profile of macitentan in tablet dosage form using a stability-indicating high performance liquid chromatography method and forced degradation study

Article

Author: Lakka, Narasimha S ; Rangasamy, Parthasarathy ; Kuppan, Chandrasekar

Macitentan (MAC) is a pulmonary arterial hypertension (PAH) drug marketed as a tablet and often has stability issues in the final dosage form. Quantitative determination of MAC and its associated impurities in tablet dosage form has not been previously reported. This study quantified impurities present in Macitentan tablets using a binary solvent-based gradient elution method using reversed phase-high performance liquid chromatography. The developed method was validated per International Conference on Harmonization (ICH) guidelines and the drug product was subjected to forced degradation studies to evaluate stability. The developed method efficiently separated the drug and impurities (48 min) without interference from solvents, excipients, or other impurities. The developed method met all guidelines in all characteristics with recoveries ranging from 85%-115%, linearity with r² ≥ 0.9966, and substantial robustness. The stability-indicating nature of the method was evaluated using stressed conditions (hydrolysis:1 N HCl at 80℃/15 min; 1 N NaOH at 25℃/45 min; humidity stress (90% relative humidity) at 25℃ for 24 h, oxidation:at 6% (v/v) H₂O₂, 80℃/15 min, thermolysis:at 105℃/16 h and photolysis:UV light at 200 Wh/m²; Fluorescent light at 1.2 million luxh). Forced degradation experiments showed that the developed method was effective for impurity profiling. All stressed samples were assayed and mass balance was>96%. Forced degradation results indicated that MAC tablets were sensitive to hydrolysis (acid and alkali) and thermal conditions. The developed method is suitable for both assay and impurity determination, which is applicable to the pharmaceutical industry.

100 Deals associated with Sinotherapeutics, Inc.

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100 Translational Medicine associated with Sinotherapeutics, Inc.

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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

NDA/BLA

2

1

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

ZX-7101A ( PA protein x RdRp )	Influenza, Human More	NDA/BLA
Linperlisib ( PI3Kδ )	Peripheral T-Cell Lymphoma More	NDA/BLA
ZL-2302 ( ALK )	Lung Cancer More	Pending