Evive Biotech, a subsidiary of Yifan Pharmaceutical (SHE: 002019), announced that the first participant has been successfully enrolled and dosed in a Phase II clinical study evaluating its self‑developed innovative drug, recombinant human interleukin‑22‑Fc fusion protein (F‑652), in combination with systemic corticosteroids for the treatment of acute graft‑versus‑host disease (aGVHD) following hematopoietic stem cell transplantation (HSCT).
Clinical Milestone
| Item | Detail |
|---|---|
| Sponsor | Evive Biotech (subsidiary of Yifan Pharmaceutical, SHE: 002019) |
| Milestone | First participant enrolled and dosed |
| Trial Phase | Phase II |
| Product | F‑652 – recombinant human interleukin‑22‑Fc fusion protein |
| Regimen | F‑652 in combination with systemic corticosteroids |
| Indication | Acute graft‑versus‑host disease (aGVHD) following hematopoietic stem cell transplantation (HSCT) |
| Milestone Date | 23 Sep 2026 |
| Next Steps | Continued enrollment and Phase II evaluation (timeline not disclosed) |
Drug Profile & Mechanism of Action
- Molecule: F‑652, a recombinant human interleukin‑22‑Fc (IgG2) fusion protein expressed in CHO cells via genetic engineering technology.
- Mechanism of Action: Mimics natural human interleukin‑22 (IL‑22), a cytokine central to epithelial tissue repair and mucosal barrier integrity – a rationale for protecting gut and other epithelial organs in aGVHD.
- Half‑Life Extension: The fused Fc fragment significantly extends the drug’s half‑life, thereby substantially enhancing clinical efficacy versus native IL‑22.
- Technology Platform: Developed by Yifan Pharmaceutical based on its proprietary Di‑Kine bimolecular technology platform.
- Innovation: A global first‑in‑class (Class 1 innovative) therapeutic biological product, self‑developed by Evive Biotech.
Disease Background – Acute GVHD After HSCT
- Condition: aGVHD is a major immune‑mediated complication following allogeneic HSCT, in which donor immune cells attack host tissues – most commonly skin, gastrointestinal tract, and liver – and remains a leading cause of transplant‑related morbidity and mortality.
- Current Standard: Systemic corticosteroids are the first‑line therapy, but a substantial proportion of patients develop steroid‑refractory or steroid‑dependent disease, with limited approved options and high unmet need.
- Therapeutic Rationale: An IL‑22‑based approach that promotes epithelial repair and barrier protection – rather than broad immunosuppression – represents a mechanistically differentiated strategy when combined with corticosteroids in the frontline setting.
Market Impact & Outlook
- First‑in‑Class Positioning: As a global first‑in‑class IL‑22‑Fc fusion protein, F‑652 is advancing into aGVHD with no direct mechanistic competitor in the same class, potentially differentiating Yifan’s biologics portfolio in transplant medicine.
- Frontline Combination Strategy: Testing F‑652 in combination with systemic corticosteroids targets the first‑line aGVHD population – the largest treatment setting – rather than the narrower steroid‑refractory niche.
- Platform Validation: Progress of F‑652 validates Yifan Pharmaceutical’s proprietary Di‑Kine bimolecular technology platform as an engine for half‑life‑extended cytokine therapeutics.
- Corporate Angle: For Yifan Pharmaceutical (SHE: 002019), the Phase II dosing milestone marks a step in the clinical maturation of its innovative‑drug pipeline beyond its established pharmaceutical base.
- Execution Watch Items: Enrollment pace, efficacy and safety readouts from the Phase II study, and the timing of investigator‑initiated or registrational next steps (not disclosed).
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the ongoing Phase II clinical study of F‑652, including enrollment, clinical outcomes, regulatory pathways, and commercial potential in acute GVHD. Actual results may differ materially due to risks including clinical setbacks, safety findings, regulatory requirements, and competitive dynamics.-Fineline Info & Tech
