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主要目的：评估在现有“北京方案”标准移植物抗宿主病（GvHD）预防的基础上加用BPC2001预防单倍型相合造血干细胞移植（haplo-SCT）后急性GvHD（aGvHD）的有效性和安全性。次要目的：评估在标准GvHD预防的基础上加用BPC2001预防haplo-SCT后慢性GvHD（cGvHD）的有效性。评估接受BPC2001预防的受试者的生存情况。评价BPC2001的药代动力学（PK）特征。探索性目的：评估III-Ⅳ度aGvHD的发生率。描述在标准GvHD预防的基础上加用BPC2001对治疗aGvHD的糖皮质激素用量和感染发生率的影响。探索BPC2001的药效动力学（PD）特征。探索与安全性相关的潜在生物标志物。

[Translation]

Primary Objectives: To evaluate the efficacy and safety of adding BPC2001 to standard graft-versus-host disease (GvHD) prophylaxis in the Beijing Protocol for the prevention of acute GvHD (aGvHD) after haploidentical hematopoietic stem cell transplantation (haplo-SCT). Secondary Objectives: To evaluate the efficacy of adding BPC2001 to standard GvHD prophylaxis for the prevention of chronic GvHD (cGvHD) after haplo-SCT. To assess the survival of participants receiving BPC2001 prophylaxis. To evaluate the pharmacokinetic (PK) characteristics of BPC2001. Exploratory Objectives: To assess the incidence of grade III-IV aGvHD. To describe the effect of adding BPC2001 to standard GvHD prophylaxis on glucocorticoid dosage and infection rates for aGvHD. To explore the pharmacodynamic (PD) characteristics of BPC2001. To explore potential biomarkers associated with safety.

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Sponsor / Collaborator

Shionogi Pharma Co., Ltd.

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100 Clinical Results associated with BioPhoenix Co., Ltd.

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0 Patents (Medical) associated with BioPhoenix Co., Ltd.

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100 Deals associated with BioPhoenix Co., Ltd.

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100 Translational Medicine associated with BioPhoenix Co., Ltd.

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Pipeline

Pipeline Snapshot as of 19 Dec 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

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