HLX 22
Alternative Names: AC-101; HLX-22Latest Information Update: 24 Dec 2025
At a glance
- Originator Alligator Bioscience
- Developer Shanghai Henlius Biotech
- Class Antineoplastics; Immunotherapies; Monoclonal antibodies
- Mechanism of Action Antibody-dependent cell cytotoxicity; T lymphocyte stimulants
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Orphan Drug Status
Yes - Gastric cancer
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Phase III Adenocarcinoma
- Phase II Breast cancer; Gastric cancer; HER2 positive breast cancer
- No development reported Solid tumours
Most Recent Events
- 09 Dec 2025 Shanghai Henlius Biotech plans a phase II/III trial for HER2 positive breast cancer (Combination therapy, Neoadjuvant therapy, Late-stage disease, First-line therapy) (Injection) in January 2026 (NCT07294534)
- 09 Dec 2025 Shanghai Henlius Biotech plans a phase II/III trial for HER2-positive-breast-cancer (Combination therapy, First-line therapy, Recurrent, Metastatic disease, Late-stage disease) in January 2026 (NCT07294508)
- 09 Dec 2025 NMPA approves IND applications for HLX 22 in combination with HLX 87 in HER 2 positive breast cancer