By Fineline Cube 
Dizal Pharmaceutical Co., Ltd. (SHA: 688192) announced that multiple research updates for its two core oncology assets—golidocitinib and birelentinib (DZD8586)—will be presented at the 67th American Society of Hematology (ASH) Annual Meeting.
Company & Meeting Context
| Item | Detail |
|---|---|
| Company | Dizal Pharmaceutical Co., Ltd. (SHA: 688192) |
| Event | 67th ASH Annual Meeting, Nov 5 – 9 , 2025 |
| Products Discussed | golidocitinib & birelentinib (DZD8586) |
| Previous US Milestone | b‑relentininib Fast‑Track designation by the FDA (Aug 2025) |
Product 1 – golidocitinib
The first‑in‑world, JAK/STAT‑pathway disruptor for Peripheral T‑cell Lymphoma (PTCL).
- Triple‑Mechanism Action
- Potent Tumor Suppression
- Anti‑Inflammatory Activity
- Immune‑Modulation
- Clinical Impact
- Breaks the treatment bottleneck for relapsed/refractory (r/r) PTCL.
- Longest median Overall Survival (mOS) among single‑agent r/r PTCL therapies reported to date.
- ASH 2025 Highlight
- Latest Phase‑II data on mOS, tumor‑response rates, and safety will be presented in the Keynote session “Novel Agents in T‑cell Lymphoma”.
Product 2 – birelentinib (DZD8586)
A global first‑in‑class, non‑covalent dual LYN/BTK inhibitor that penetrates the blood‑brain barrier.
| Phase | Status | Indication |
|---|---|---|
| Phase I/II | Ongoing | r/r Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) after BTK inhibitor or degrader exposure |
| FDA Fast‑Track | Granted (Aug 2025) | r/r CLL/SLL |
- Key ASH 2025 Data
- Early safety and efficacy signals in heavily pre‑treated CLL/SLL patients.
- Biomarker insights on BTK degrader resistance and blood‑brain barrier penetration.
- Prior Conferences
- Oral presentations at ASCO 2025 and ICML 2025 highlighted the drug’s unique non‑covalent chemistry and CNS accessibility.
Market & Regulatory Significance
- ASH 2025 Platform – A high‑profile venue that can accelerate global recognition and facilitate interactions with the worldwide hematology community.
- Fast‑Track Status – Signals the FDA’s recognition of the unmet need in r/r CLL/SLL, potentially shortening the U.S. approval timeline.
- China‑US Parallel Track – Dizal’s simultaneous pursuit of regulatory pathways in China and the U.S. positions the company to capture both domestic and international markets.
Bottom Line
Dizal’s announcement underscores a dual‑product strategy:
- golidocitinib—the only new‑mechanism JAK/STAT inhibitor delivering the longest mOS in r/r PTCL—addresses an urgent unmet need in aggressive T‑cell disease.
- birelentinib—a first‑in‑class LYN/BTK dual blocker with CNS penetration—extends treatment options for heavily pre‑treated CLL/SLL patients, bolstered by FDA Fast‑Track designation.
The ASH 2025 disclosures are poised to further elevate Dizal’s profile among clinicians, investors, and pay‑or‑perform‑in‑care buyers globally.-Fineline Info & Tech