[Translation] A randomized, double-blind, positive-controlled, multicenter clinical study comparing the pharmacokinetics, efficacy, safety, and immunogenicity similarity of BLB101 injection and belintolimab injection (Blincyto®) in adult participants with relapsed or refractory CD19-positive pro-B-cell acute lymphoblastic leukemia.

主要目的： 1.比较注射用BLB101与注射用贝林妥欧单抗（Blincyto®）在治疗R/R B-ALL参与者中的药代动力学相似性。 2.比较注射用BLB101与注射用贝林妥欧单抗（Blincyto®）在治疗R/R B-ALL参与者中的疗效相似性。次要目的： 1.评价注射用BLB101与注射用贝林妥欧单抗（Blincyto®）在治疗R/R B-ALL参与者中的安全性。 2.评价注射用BLB101与注射用贝林妥欧单抗（Blincyto®）在治疗R/R B-ALL参与者中的免疫原性。 3.比较注射用BLB101与注射用贝林妥欧单抗（Blincyto®）在治疗R/R B-ALL参与者中的其它药代动力学特征。 4.比较注射用BLB101与注射用贝林妥欧单抗（Blincyto®）在治疗R/R B-ALL参与者中的其它有效性指标。 5.探索评价注射用BLB101与注射用贝林妥欧单抗（Blincyto®）在治疗R/R B-ALL参与者的药效学。

[Translation]

Primary Objectives: 1. To compare the pharmacokinetic similarity between BLB101 for injection and Blincyto® for injection in participants treating recurrent or recurrent bacillary ALL (R/R B-ALL). 2. To compare the efficacy similarity between BLB101 for injection and Blincyto® for injection in participants treating R/R B-ALL. Secondary Objectives: 1. To evaluate the safety of BLB101 for injection and Blincyto® for injection in participants treating R/R B-ALL. 2. To evaluate the immunogenicity of BLB101 for injection and Blincyto® for injection in participants treating R/R B-ALL. 3. To compare other pharmacokinetic characteristics of BLB101 for injection and Blincyto® for injection in participants treating R/R B-ALL. 4. Compare other efficacy endpoints of BLB101 for injection and Blincyto® for injection in participants treating R/R B-ALL. 5. Explore and evaluate the pharmacodynamics of BLB101 for injection and Blincyto® for injection in participants treating R/R B-ALL.

Start Date-

Sponsor / Collaborator

Beijing Libang Biomedicine Co., Ltd.

100 Clinical Results associated with BLB-101

100 Translational Medicine associated with BLB-101

100 Patents (Medical) associated with BLB-101

100 Deals associated with BLB-101

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC19	-

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
CD19-positive B-cell Precursor acute lymphoblastic leukemia	Clinical	China	Beijing Libang Biomedicine Co., Ltd.	05 Mar 2026
Hematologic Neoplasms	Preclinical	China	Chime Biologics Ltd.	10 Dec 2025

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