Delving into the Latest Updates on Shijiazhuang Zhikang Hongren New Drug Development Co., Ltd. with Synapse

Overview

Tags

Neoplasms

Other Diseases

Respiratory 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

Neoplasms	3
Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Small molecule drug	4

Top 5 Target	Count

FGFRs(Fibroblast growth factor receptors)	1
WEE1(Serine/threonine-protein kinase WEE1)	1
ATR(Serine-protein kinase ATR)	1

第一阶段（剂量递增阶段）：主要目的： -评估 SC0245 单药在晚期恶性实体瘤患者的安全性和耐受性； -确定 SC0245 的剂量限制毒性（Dose-Limiting Toxicity， DLT）和最大耐受剂量（MTD）或 II 期推荐剂量（RP2D）。次要目的： - 评估 SC0245 单药在晚期恶性实体瘤患者中的药代动力学（PK）特征； -评估 SC0245 单药在晚期恶性实体瘤患者中的初步抗肿瘤活性。第二阶段（剂量扩展阶段）主要目的：进一步评估 SC0245 单药在晚期恶性实体瘤患者的安全性和耐受性。次要目的： -进一步在多种特定肿瘤类型中初步评价 SC0245 单药在晚期恶性实体瘤患者中的抗肿瘤活性。 -进一步探索生物标记物与临床疗效之间的关系。

[Translation]

Phase I (Dose Escalation Phase): Primary Objectives: - To evaluate the safety and tolerability of SC0245 monotherapy in patients with advanced malignant solid tumors; - To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) or Phase II recommended dose (RP2D) of SC0245. Secondary Objectives: - To evaluate the pharmacokinetic (PK) characteristics of SC0245 monotherapy in patients with advanced malignant solid tumors; - To evaluate the preliminary anti-tumor activity of SC0245 monotherapy in patients with advanced malignant solid tumors. Phase II (Dose Expansion Phase) Primary Objectives: To further evaluate the safety and tolerability of SC0245 monotherapy in patients with advanced malignant solid tumors. Secondary Objectives: - To further preliminarily evaluate the anti-tumor activity of SC0245 monotherapy in patients with advanced malignant solid tumors in multiple specific tumor types. - To further explore the relationship between biomarkers and clinical efficacy.

Start Date29 Jun 2021

Sponsor / Collaborator

Shijiazhuang Zhikang Hongren New Drug Development Co., Ltd.

CTR20210649

/ RecruitingPhase 1

一项开放、单臂的I期临床研究：评价SC0191片在晚期恶性实体瘤患者中的安全性、耐受性、药代动力学特征和药效动力学特征，并初步探索SC0191片的抗肿瘤活性

[Translation] An open, single-arm Phase I clinical study: To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of SC0191 tablets in patients with advanced malignant solid tumors, and to preliminarily explore the anti-tumor activity of SC0191 tablets

主要目的： - 评估SC0191片单药在晚期恶性实体瘤患者中的DLT发生情况（剂量爬坡期）； - 确定SC0191片单药的II期临床推荐剂量（RP2D）（剂量爬坡期）； - 评估SC0191片单药在晚期恶性实体瘤患者中的安全性和耐受性；次要目的： - 评估SC0191片单药在晚期恶性实体瘤患者中的药代动力学（PK）特征； - 评估SC0191片单药在晚期恶性实体瘤患者中的初步抗肿瘤活性。

[Translation]

Primary objectives: - To evaluate the occurrence of DLT of SC0191 tablets alone in patients with advanced malignant solid tumors (dose escalation phase); - To determine the recommended dose (RP2D) of SC0191 tablets alone in Phase II clinical trials (dose escalation phase); - To evaluate the safety and tolerability of SC0191 tablets alone in patients with advanced malignant solid tumors; Secondary objectives: - To evaluate the pharmacokinetic (PK) characteristics of SC0191 tablets alone in patients with advanced malignant solid tumors; - To evaluate the preliminary anti-tumor activity of SC0191 tablets alone in patients with advanced malignant solid tumors.

Start Date25 Jun 2021

Sponsor / Collaborator

Shijiazhuang Zhikang Hongren New Drug Development Co., Ltd.

CTR20210215

/ RecruitingPhase 1

一项多中心、开放、单臂、非随机的I 期临床试验：评估泛FGFR 抑制剂SC0011 片在晚期恶性实体瘤患者的安全性、耐受性、药代动力学及药效动力学特征，并初步探索SC0011 片的抗肿瘤活性

[Translation] A multicenter, open, single-arm, non-randomized Phase I clinical trial: To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the pan-FGFR inhibitor SC0011 tablets in patients with advanced malignant solid tumors, and to preliminarily explore the anti-tumor activity of SC0011 tablets

1、评价SC0011 片的安全性和耐受性； 2、确定SC0011 片的最大耐受剂量（MTD）和II 期推荐剂量（RP2D）； 3、评价SC0011 片的药代动力学（PK）特征； 4、评价SC0011 片的药效动力学（PD）特征； 5、初步评价SC0011 片的抗肿瘤活性； 6、初步评价在FGFR 基因检测异常受试者中SC0011 片的疗效。

[Translation]

1. Evaluate the safety and tolerability of SC0011 tablets; 2. Determine the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) of SC0011 tablets; 3. Evaluate the pharmacokinetic (PK) characteristics of SC0011 tablets; 4. Evaluate the pharmacodynamic (PD) characteristics of SC0011 tablets; 5. Preliminary evaluation of the anti-tumor activity of SC0011 tablets; 6. Preliminary evaluation of the efficacy of SC0011 tablets in subjects with abnormal FGFR gene detection.

Start Date04 Mar 2021

Sponsor / Collaborator

Shijiazhuang Zhikang Hongren New Drug Development Co., Ltd.

100 Clinical Results associated with Shijiazhuang Zhikang Hongren New Drug Development Co., Ltd.

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0 Patents (Medical) associated with Shijiazhuang Zhikang Hongren New Drug Development Co., Ltd.

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100 Deals associated with Shijiazhuang Zhikang Hongren New Drug Development Co., Ltd.

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100 Translational Medicine associated with Shijiazhuang Zhikang Hongren New Drug Development Co., Ltd.

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Pipeline

Pipeline Snapshot as of 30 Aug 2025

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 1

4

3

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

SC-0245 ( ATR )	Advanced Malignant Solid Neoplasm More	Phase 1
SC-0011 ( FGFRs )	Advanced Malignant Solid Neoplasm More	Phase 1
Sufenidone	Idiopathic Pulmonary Fibrosis More	Phase 1
SC-0191 ( WEE1 )	Advanced Malignant Solid Neoplasm More	Phase 1
WXSH0081	Inflammatory Bowel Diseases More	Discontinued