Delving into the Latest Updates on BH259 with Synapse

Overview

Basic Info

Drug Type

Peptide drug conjugates

Synonyms

BH259

Target-

Action-

Mechanism-

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Zhuhai Beihai Biotechnology Co., Ltd.

Active Organization

Zhuhai Beihai Biotechnology Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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Structure/Sequence

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主要目的：Ⅰ期：确认BH259在晚期实体瘤患者中的MTD 和RP2D，并评估其剂量限制性毒性（DLT）；Ⅱ期：评估BH259在晚期实体瘤患者中的初步有效性。次要目的：Ⅰ期：评估BH259的安全性、耐受性、药代动力学特征及初步抗肿瘤活性；Ⅱ期：评估BH259在晚期实体瘤患者中的安全性，并验证其RP2D。

[Translation]

Primary objectives: Phase I: confirm the MTD and RP2D of BH259 in patients with advanced solid tumors, and evaluate its dose-limiting toxicity (DLT); Phase II: evaluate the preliminary efficacy of BH259 in patients with advanced solid tumors. Secondary objectives: Phase I: evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor activity of BH259; Phase II: evaluate the safety of BH259 in patients with advanced solid tumors, and verify its RP2D.

Start Date-

Sponsor / Collaborator

Zhuhai Beihai Biotechnology Co., Ltd.

100 Clinical Results associated with BH259

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100 Translational Medicine associated with BH259

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100 Patents (Medical) associated with BH259

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100 Deals associated with BH259

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	China	Zhuhai Beihai Biotechnology Co., Ltd.	14 May 2025

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Clinical Result

Indication

Phase

Evaluation

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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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