Drug Profile
Pertuzumab biosimilar - Shanghai Henlius Biotech
Alternative Names: Anti-HER2 monoclonal antibody - Shanghai Henlius Biotech; HLX 11Latest Information Update: 27 Feb 2024
Price :
$50
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At a glance
- Originator Shanghai Henlius Biotech
- Class Antineoplastics; Immunotherapies; Monoclonal antibodies
- Mechanism of Action Antibody-dependent cell cytotoxicity; Dimerisation inhibitors
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Phase III HER2 positive breast cancer
Most Recent Events
- 28 Oct 2022 Shanghai Henlius Biotech submits clinical trial application for HLX 11 in other EU countries including Poland, Bulgaria, Hungary, and the Czech Republic (Shanghai Henlius Biotech pipeline, February 2023)
- 28 Oct 2022 The Spanish Agency of Medicines and Medical Devices approves a clinical trial application for a phase III trial in Breast cancer in European Union (Shanghai Henlius Biotech pipeline, February 2024)
- 13 Jun 2022 Pertuzumab biosimilar marketing rights licensed to Organon in USA, European Union, Japan, as well as a number of undisclosed emerging markets (except China, Taiwan, Hong Kong and Macau)