Delving into the Latest Updates on HB-48 with Synapse

Overview

Basic Info

Drug Type

Chemical drugs

Synonyms

HB-48

Target-

Action-

Mechanism-

Therapeutic Areas

NeoplasmsNervous System DiseasesOther Diseases

Active Indication

GlioblastomaRecurrent Glioblastoma

Inactive Indication-

Originator Organization

Guchong Medicine (Beijing) Co., Ltd.

Active Organization

Guchong Medicine (Beijing) Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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剂量递增阶段（1期）主要目的：评价HB-48片治疗rGBM患者中的安全性、耐受性；确定最大耐受剂量（MTD）和/或临床试验Ⅱ期推荐剂量（RP2D）次要目的： 1）评价HB-48片及其代谢产物在rGBM患者中的药代动力学（PK）特征。 2）初步评价HB-48片在rGBM患者中的有效性。 3）评价生物标志物的变化与疗效的关系。 4）评价生物标志物的变化与HB-48片的暴露之间的关系。队列扩展阶段（II期）主要目的：评价HB-48片在rGBM患者中的有效性。次要目的： 1）评价HB-48片及其代谢产物在rGBM患者中的药代动力学（PK）特征。 2）评价HB-48片在rGBM患者中的安全性。 3）评价生物标志物的变化与疗效的关系。

[Translation]

Dose Escalation Phase (Phase 1) Primary Objectives: To evaluate the safety and tolerability of HB-48 tablets in patients with rGBM; to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) for clinical trials. Secondary Objectives: 1) To evaluate the pharmacokinetic (PK) characteristics of HB-48 tablets and its metabolites in patients with rGBM. 2) To preliminarily evaluate the efficacy of HB-48 tablets in patients with rGBM. 3) To evaluate the relationship between changes in biomarkers and efficacy. 4) To evaluate the relationship between changes in biomarkers and exposure to HB-48 tablets. Cohort Expansion Phase (Phase II) Primary Objectives: To evaluate the efficacy of HB-48 tablets in patients with rGBM. Secondary Objectives: 1) To evaluate the pharmacokinetic (PK) characteristics of HB-48 tablets and its metabolites in patients with rGBM. 2) To evaluate the safety of HB-48 tablets in patients with rGBM. 3) To evaluate the relationship between changes in biomarkers and efficacy.

Start Date-

Sponsor / Collaborator

Guchong Medicine (Beijing) Co., Ltd.

100 Clinical Results associated with HB-48

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100 Translational Medicine associated with HB-48

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100 Patents (Medical) associated with HB-48

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100 Deals associated with HB-48

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glioblastoma	Phase 2	China	Guchong Medicine (Beijing) Co., Ltd.	22 Aug 2025
Recurrent Glioblastoma	IND Approval	China	Guchong Medicine (Beijing) Co., Ltd.	26 Mar 2025