Evidence map›Paper›PMID 42609242›Full record

ArticleFrontiers in pharmacology2026

Terminus-specific antibody development and bioanalytical assay validation to quantify active DR10624 in pharmacokinetic studies.

Zhenxing Zhou, Kexin Cao, Gaofeng Yao, Yuanyuan Liu, Wenwen Duan, Chengcheng Yang, Shimei Sheng, Yanshan Huang

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Article in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

8 authors.

Zhenxing ZhouDepartment of Innovative Drug Discovery and Development, Zhejiang Doer Biologics Co., Ltd., Hangzhou, China.
Kexin CaoDepartment of Innovative Drug Discovery and Development, Zhejiang Doer Biologics Co., Ltd., Hangzhou, China.
Gaofeng YaoDepartment of Innovative Drug Discovery and Development, Zhejiang Doer Biologics Co., Ltd., Hangzhou, China.
Yuanyuan LiuDepartment of Innovative Drug Discovery and Development, Zhejiang Doer Biologics Co., Ltd., Hangzhou, China.
Wenwen DuanDepartment of Innovative Drug Discovery and Development, Zhejiang Doer Biologics Co., Ltd., Hangzhou, China.
Chengcheng YangDepartment of Innovative Drug Discovery and Development, Zhejiang Doer Biologics Co., Ltd., Hangzhou, China.
Shimei ShengDepartment of Innovative Drug Discovery and Development, Zhejiang Doer Biologics Co., Ltd., Hangzhou, China.
Yanshan HuangDepartment of Innovative Drug Discovery and Development, Zhejiang Doer Biologics Co., Ltd., Hangzhou, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Multi-specific drugs play important roles in addressing multi-factorial disease conditions. DR10624 is a first-in-class long acting Fc fusion triple agonist targeting FGF21R, GLP-1R, and GCGR, which has shown promising efficacy in reducing liver fat and triglycerides. Accurate quantification of the intact, pharmacologically active form of DR10624 in serum is essential for reliable pharmacokinetic (PK) characterization. Methods: Rabbit monoclonal antibodies that specifically recognize the N- and C-termini regions of DR10624 were developed and strategically paired for precise quantification. An electrochemiluminescence (ECL) based immunoassay was established and rigorously validated in accordance with regulatory guidelines. Additionally, a preclinical pharmacokinetic study in cynomolgus monkeys was performed to compare drug exposure using different assay formats. Results: Antibody screening successfully identified highly specific rabbit monoclonal antibodies, notably clones 4G7 and 1A12, which selectively bound to the intact N- and C-termini of DR10624 and effectively neutralized its GLP-1/GCG and FGF21 activities, respectively. Furthermore, the preclinical pharmacokinetic study in cynomolgus monkeys revealed a marked discrepancy between total and intact DR10624 exposure, indicating Discussion: The validated dual-monoclonal ECL method provides a robust and specific approach for quantifying intact, bioactive DR10624 in human serum. This assay supports reliable PK assessment in ongoing and future clinical trials, facilitating the continued development of DR10624 for the treatment of MASLD/MASH, severe hypertriglyceridemia (SHTG), and related metabolic diseases.

Indexed as

DR10624immunoassaymethod validationmulti-specific drugpharmacokinetics

Identifiers

PMID42609242
PMCPMC13477871

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