Ozmosi | HLX-11 Drug Profile
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HLX-11

Alternative Names: hlx-11, hlx 11, hlx11
Clinical Status: Active
Latest Update: 2025-11-06
Latest Update Note: Clinical Trial Update

Product Description

HLX11 is a proposed biosimilar of pertuzumab (originator trade name: Perjeta®) (Sourced from: https://henlius.com/en/NewsDetails-2306-26.html)

Mechanisms of Action: EGFR2 Inhibitor

Novel Mechanism: Yes

Modality: Antibody

Route of Administration: Intravenous

FDA Designation: *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Henlius Biotech
Company Location:
Company CEO:
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for HLX-11

Countries in Clinic: Bulgaria, China, Poland, Spain

Active Clinical Trial Count: 2

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Breast Cancer

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

CTR20220391

CTR20220391

P3

Completed

Breast Cancer

2025-09-30

2025-11-02

Primary Completion Date|Study Completion Date|Treatments|Trial Status

NCT05346224

HLX11-BC301

P3

Active, not recruiting

Breast Cancer

2024-05-15

35%

2025-02-28

Primary Completion Date|Primary Endpoints