Drugs / ALK201
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT06656390 | Oct 2024 → Oct 2027 expected | cancer | Shanghai Allink Biotherapeutics Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-07-29 | Shanghai Allink Biotherapeutics Co., Ltd. | Regulatory Allink Biotherapeutics and Akeso Announce Clinical Collaboration to Evaluate FGFR2b ADC Plus Ivonescimab for Squamous Cell Lung Cancer allinkbio.com ↗
Investigational New Drug (IND) application of ALK201 Phase II trial has been officially approved by China's National Medical Products Administration (NMPA). |
| 2026-05-30 | Shanghai Allink Biotherapeutics Co., Ltd. | Results Allink Biotherapeutics to Present First Clinical Data for ALK201 ( FGFR2b-Targeting ADC) in Advanced Solid Tumors at ASCO 2026 allinkbio.com ↗
The latest dose-escalation results show that ALK201 monotherapy has a favorable safety profile and promising anti-cancer activity in pretreated advanced solid tumors. |
| 2026-04-30 | Shanghai Allink Biotherapeutics Co., Ltd. | Regulatory AllinkBio’s ALK201 Granted Orphan Drug Designation in Gastric Cancer by the US FDA allinkbio.com ↗
Allink Biotherapeutics, Inc. (AllinkBio), a clinical-stage biotechnology company focusing on developing advanced antibody-drug conjugates (ADCs) and multi-specific antibody therapeutics for oncology and immunology, today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to ALK201, an ADC targeting the fibroblast growth factor receptor-2b (FGFR2b), for gastric cancer. |
| 2024-11-21 | Shanghai Allink Biotherapeutics Co., Ltd. | Regulatory U.S. FDA IND Clearance and First Patient Dosed in Australia for First Oncology ADC Program ALK201 allinkbio.com ↗
The U.S. Food and Drug Administration (FDA) just cleared the company's Investigational New Drug (IND) application, and first patient has been successfully dosed in Australia. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-29 | Shanghai Allink Biotherapeutics Co., Ltd. | Allink Biotherapeutics and Akeso Announce Clinical Collaboration to Evaluate FGFR2b ADC Plus Ivonescimab for Squamous Cell Lung Cancer allinkbio.com ↗ |
| 2026-05-30 | Shanghai Allink Biotherapeutics Co., Ltd. | Allink Biotherapeutics to Present First Clinical Data for ALK201 ( FGFR2b-Targeting ADC) in Advanced Solid Tumors at ASCO 2026 allinkbio.com ↗ |
| 2026-04-30 | Shanghai Allink Biotherapeutics Co., Ltd. | AllinkBio’s ALK201 Granted Orphan Drug Designation in Gastric Cancer by the US FDA allinkbio.com ↗ |
| 2025-03-31 | Shanghai Allink Biotherapeutics Co., Ltd. | Late-Breaking Preclinical Results of ALK201 Presenting at 2025 AACR Annual Meeting allinkbio.com ↗ |
| 2024-11-21 | Shanghai Allink Biotherapeutics Co., Ltd. | U.S. FDA IND Clearance and First Patient Dosed in Australia for First Oncology ADC Program ALK201 allinkbio.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ALK201 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06656390 ↗ |
| Route | Intravenous | “Administered intravenously, once every 3 weeks” NCT06656390 ↗ |