Delving into the Latest Updates on Shengke Pharmaceutical (Jiangsu) Co., Ltd. with Synapse

Overview

Tags

Neoplasms

Immune System 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

Neoplasms	5
Immune System Diseases	2
Hemic and Lymphatic Diseases	2
Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Small molecule drug	4
Unknown	2

Top 5 Target	Count

PCSK9(Proprotein convertase subtilisin kexin type 9)	1
NTRK(Neurotrophic tyrosine kinase receptor)	1
CDK4 x CDK6 x PIM3	1
CDK6 x CSF-1R x FLT3	1
CDK x TrkC	1

主要目的： 1. 评价 ETH-155008在复发性或难治性急性髓系白血病（AML）和非霍奇金淋巴瘤（NHL）患者的安全性和耐受性， 2. 确定ETH-155008的最大耐受剂量（MTD），以及II期推荐剂量（RP2D）。次要目的： 1. 评价 ETH-155008 在复发性或难治性AML和NHL患者中单次、多次口服给药后的药代动力学（PK）特征； 2. 评价 ETH-155008 的药效动力学（PD）特征； 3. 评价 ETH-155008 在复发性或难治性AML和NHL患者中的初步抗肿瘤疗效。 4. 评价对ETH-155008治疗反应的生物标志物，可能包括但不限于与有效/耐药相关的基因突变和表达特征。

[Translation]

Primary objectives: 1. To evaluate the safety and tolerability of ETH-155008 in patients with relapsed or refractory acute myeloid leukemia (AML) and non-Hodgkin's lymphoma (NHL); 2. To determine the maximum tolerated dose (MTD) of ETH-155008 and the recommended dose (RP2D) for Phase II. Secondary objectives: 1. To evaluate the pharmacokinetic (PK) characteristics of ETH-155008 in patients with relapsed or refractory AML and NHL after single and multiple oral administrations; 2. To evaluate the pharmacodynamic (PD) characteristics of ETH-155008; 3. To evaluate the preliminary anti-tumor efficacy of ETH-155008 in patients with relapsed or refractory AML and NHL. 4. To evaluate biomarkers of response to ETH-155008 treatment, which may include but are not limited to gene mutations and expression characteristics associated with efficacy/resistance.

Start Date27 Oct 2022

Sponsor / Collaborator

Shengke Pharmaceutical (Jiangsu) Co., Ltd.

NCT04840784 / TerminatedPhase 1

A Phase 1a/1b Dose Escalation and Dose Expansion, First-in-human, Open-Labeled Study of ETH-155008 in Subjects With Relapsed or Refractory B-cell NHL, CLL/SLL and AML

This Trial is a FIH, open-label, multicenter trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ETH-155008 in subjects with R/R B-cell NHL, CLL/SLL and AML who previously received standard treatment or are ineligible for standard treatment options.

Start Date29 Jun 2021

Sponsor / Collaborator

Shengke Pharmaceutical (Jiangsu) Co., Ltd.

100 Clinical Results associated with Shengke Pharmaceutical (Jiangsu) Co., Ltd.

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0 Patents (Medical) associated with Shengke Pharmaceutical (Jiangsu) Co., Ltd.

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100 Deals associated with Shengke Pharmaceutical (Jiangsu) Co., Ltd.

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100 Translational Medicine associated with Shengke Pharmaceutical (Jiangsu) Co., Ltd.

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Pipeline

Pipeline Snapshot as of 23 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

Discovery

3

1

Preclinical

IND Approval

1

Phase 1 Clinical

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

ETH-155008 ( CDK4 x CDK6 x PIM3 )	Non-Hodgkin Lymphoma More	Phase 1
ETH-155036 ( CDK6 x CSF-1R x FLT3 )	Relapsing acute myeloid leukemia More	IND Approval
ETH-201 ( PCSK9 )	Cardiovascular Diseases More	Preclinical
ETH-154 ( CDK x TrkC )	Squamous Cell Carcinoma of Head and Neck More	Discovery
ETH-168 ( NTRK )	Solid tumor More	Discovery