Delving into the Latest Updates on Taizhou Hongyun Pharmaceutical Co., Ltd. with Synapse

Overview

Tags

Neoplasms

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	7

Top 5 Drug Type	Count

Small molecule drug	11

Top 5 Target	Count

EGFR(Epidermal growth factor receptor erbB1)	3
HPK1(Mitogen-activated protein kinase kinase kinase kinase 1)	2
EGFR C797S(Epidermal Growth Factor Receptor C797S)	2

This is a phase I/IIa, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of H002 when given orally in patients with active EGFR mutation locally advanced or metastatic non-small cell lung cancer (NSCLC).
The study will contain two parts: Part A is dose escalation phase (i.e., Phase I) and Part B is dose expansion phase (i.e., Phase IIa).

Start Date15 Dec 2022

Sponsor / Collaborator

Taizhou Hongyun Pharmaceutical Co., Ltd.

[+1]

NCT05552781 / RecruitingPhase 1/2

A Phase I/IIa, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Anti-tumor Activity of H002 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLC

This is a phase I/IIa, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of H002 when given orally in patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
The study will contain two parts: Part A is dose escalation phase (i.e., Phase I) and Part B is dose expansion phase (i.e., Phase IIa).

Start Date26 Aug 2022

Sponsor / Collaborator

Taizhou Hongyun Pharmaceutical Co., Ltd.

[+1]

CTR20221554 / RecruitingPhase 1/2

一项评价H002在表皮生长因子受体突变阳性的局部晚期或转移性非小细胞肺癌患者中的安全性、耐受性、药代动力学和初步抗肿瘤活性的开放性、剂量递增和扩展的I/IIa期临床研究

[Translation] An open-label, dose-escalation and expansion phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of H002 in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor mutation-positive

评估H002的安全性和耐受性，并确定最大耐受剂量（MTD）或最佳生物效应剂量（OBD）/II期推荐剂量（RP2D）。评估H002口服给药的药代动力学（PK）特征。评估H002治疗的初步抗肿瘤作用。

[Translation]

To evaluate the safety and tolerability of H002 and determine the maximum tolerated dose (MTD) or optimal biological effect dose (OBD)/recommended dose for Phase II (RP2D). To evaluate the pharmacokinetic (PK) characteristics of oral administration of H002. To evaluate the preliminary anti-tumor effect of H002 treatment.

Start Date12 Aug 2022

Sponsor / Collaborator

Taizhou Hongyun Pharmaceutical Co., Ltd.

100 Clinical Results associated with Taizhou Hongyun Pharmaceutical Co., Ltd.

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0 Patents (Medical) associated with Taizhou Hongyun Pharmaceutical Co., Ltd.

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100 Deals associated with Taizhou Hongyun Pharmaceutical Co., Ltd.

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100 Translational Medicine associated with Taizhou Hongyun Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 03 Jan 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

Discovery

4

6

Preclinical

Phase 2

1

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

H002 ( EGFR C797S )	Non-Small Cell Lung Cancer More	Phase 1/2
RC-08 ( HPK1 )	Solid tumor More	Preclinical
RC-01 (Hongyun Biotech) ( EGFR C797S )	Non-Small Cell Lung Cancer More	Preclinical
RC-06	Solid tumor More	Preclinical
RC-01-D ( EGFR )	Non-Small Cell Lung Cancer More	Discovery