Drug intelligence / Profile preview

QL1209

Development stage
Phase 3
Lead developer
Qilu Pharmaceutical
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

QL1209 is a biosimilar to pertuzumab, developed by Qilu Pharmaceutical, designed for the treatment of HER2-positive, estrogen receptor/progesterone receptor-negative early or locally advanced breast cancer. It is a recombinant humanized monoclonal antibody that targets the HER2 (ERBB2) receptor and functions as a dimerization inhibitor. In phase III clinical trials, QL1209 demonstrated equivalent efficacy and safety compared to reference pertuzumab (Perjeta), with similar pathologic complete response rates and adverse event profiles when used in combination with trastuzumab and docetaxel as neoadjuvant therapy. The drug acts primarily by inhibiting HER2 dimerization, thereby blocking downstream signaling pathways involved in tumor cell proliferation and survival. Pharmacokinetic studies confirmed high similarity between QL1209 and Perjeta in healthy subjects[1][2][4][5].

Other names
pertuzumab biosimilar (Qilu Pharmaceutical)帕妥珠单抗生物类似药(齐鲁制药有限公司)重组抗HER2结构域Ⅱ人源化单抗 (齐鲁制药)
02

Targets

ERBB2 (Erb-b2 receptor tyrosine kinase 2)

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