Drug Type Fc fusion protein |
Synonyms Recombinant human SIRPα-IgG4 Fc Fusion Protein(Henlius), 重组人SIRPα-IgG4 Fc融合蛋白(复宏汉霖), HCB 101 + [2] |
Target |
Action modulators |
Mechanism CD47 modulators(Cluster of differentiation 47 modulators), SIRPα modulators(Signal-regulatory protein alpha modulators) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhasePhase 1/2 |
First Approval Date- |
RegulationOrphan Drug (United States) |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| RAS/BRAF Wild Type Colorectal Cancer | Phase 2 | China | 06 Mar 2026 | |
| RAS/BRAF Wild Type Colorectal Cancer | Phase 2 | China | 06 Mar 2026 | |
| Squamous cell carcinoma of head and neck metastatic | Phase 2 | Taiwan Province | 13 Aug 2025 | |
| Metastatic Colorectal Carcinoma | Phase 2 | Taiwan Province | 14 May 2025 | |
| Advanced Malignant Solid Neoplasm | Phase 2 | China | 13 Mar 2025 | |
| Metastatic gastric adenocarcinoma | Phase 1 | China | 28 Feb 2025 | |
| Triple Negative Breast Cancer | Phase 1 | China | 28 Feb 2025 | |
| Hematologic Neoplasms | Phase 1 | United States | 02 Oct 2023 | |
| Hematologic Neoplasms | Phase 1 | China | 02 Oct 2023 | |
| Hematologic Neoplasms | Phase 1 | Taiwan Province | 02 Oct 2023 |
Phase 1/2 | - | HCB101 monotherapy (HCB101-101) | niulowytrh(wszdgoxkgy) = HCB101-101: Clean, cytopenia-sparing safety across 12 cohorts up to 36 mg/kg QW. No bleeding events or immune-related toxicities, with the majority of TRAEs being Grade 1-2.
HCB101‑201: No new safety signals across all evaluated combinations. Cytopenias fully attributable to chemotherapy, not HCB101. zeegazffum (zckhmaabpi ) View more | Positive | 10 Dec 2025 | ||
(HCB101‑201, 2L GC Cohort) | |||||||
Phase 1 | 12 | (relapsed/refractory non-Hodgkin lymphoma) | vqbhroogtv(qiohiqjriy) = the most common being leukopenia (25.0%), neutropenia (22.9%), anemia (20.8%), and thrombocytopenia (6.3%), eibkuwoklj (mtnarvmlgh ) | Positive | 06 Dec 2025 | ||
Phase 1/2 | 2 | HCB101 + Pembrolizumab | ilsbnybudw(fjnwnjvhhf) = pvktdvicxz zedaclkwne (icggtipxbs ) View more | Positive | 30 Oct 2025 | ||
Phase 1/2 | 9 | HCB101 + standard therapy | xkhxizgkty(airifiaagw) = ycppmvwcwj omhpzlppmv (odftqqhrry ) View more | Positive | 29 Oct 2025 | ||
NCT05892718 (PRNewswire) Manual | Phase 1 | 49 | tfncqjqqek(nxlsreqeyc) = iwawkqbfwc myooulsvas (peqxfjgoyl ) View more | Positive | 23 Oct 2025 | ||
NCT05892718 (ASCO2025) Manual | Phase 1 | 32 | puwoovuswd(pbabguctem) = ijrddfljpn npmsbsdnhl (gxlxacjmqn ) View more | Positive | 30 May 2025 |






