Drug Profile
Trastuzumab biosimilar - Shanghai Henlius Biotech
Alternative Names: Dafex; Hanquyou; HLX 02; Trastucip; Tuzucip; ZercepacLatest Information Update: 25 Mar 2024
Price :
$50
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At a glance
- Originator Shanghai Henlius Biotech
- Developer Accord Healthcare; Cipla; Shanghai Henlius Biotech
- Class Antineoplastics; Immunotherapies; Monoclonal antibodies
- Mechanism of Action Antibody-dependent cell cytotoxicity; ERBB 2 receptor antagonists
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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
- Marketed Breast cancer; Gastric cancer
Most Recent Events
- 21 Mar 2024 Henlius expects Marketing application approval from Health Canada for Breast cancer in 2024
- 21 Mar 2024 Henlius expects Marketing application approval from US FDA for Breast cancer and Gastric cancer in 2024
- 15 Aug 2023 US FDA accepts BLA for trastuzumab biosimilar for Breast cancer and Gastric cancer for review