• Golidocitinib monotherapy showed high and durable response in adults with secondary HLH, to be featured in an oral presentation.
• Two oral presentations showing superior clinical benefits of birelentinib, as a single agent or in combination with a BCL2 inhibitor, in 1^st line CLL/SLL

SHANGHAI, Nov. 5, 2026 /PRNewswire/ -- Dizal (SSE: 688192), a biopharmaceutical company dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of oncology and hematological diseases, announced today that it will present its latest clinical results from its hematological disease portfolio with three oral and five poster presentations, at the 68^th American Society of Hematology (ASH) Annual Meeting. The oral sessions will feature clinical studies evaluating golidocitinib and birelentinib in lymphoma and hematologic immune diseases. The clinical data for GW5282 in relapsed or refractory non-Hodgkin lymphoma (r/r NHL) will be presented for the first time.

Dr. Xiaolin Zhang, CEO of Dizal, said: "Dizal has a globally competitive hematological disease portfolio. Our robust presence at ASH 2026 reflects the exciting advancement of our differentiated portfolio in T-cell and B-cell lymphomas, as well as autoimmune diseases. We believe these programs will bring the next generation of novel therapies to patients globally."

Golidocitinib in PTCL and HLH

Golidocitinib is the world's first and only Janus kinase 1 (JAK1) inhibitor approved for the treatment of relapsed or refractory peripheral T-cell lymphoma (r/r PTCL). It has shown promising preliminary efficacy across T-cell lymphoma subtypes and selected hematologic immune diseases.

• An oral presentation will feature updated data in adults with secondary hemophagocytic lymphohistiocytosis (HLH), extending the previous findings reported at the European Hematology Association (EHA) Congress 2026 (Abstract #PF700). The results demonstrate that golidocitinib, as a single agent, can achieve high and durable response rates with a manageable safety profile, supporting further development of the drug in this devastating disease.
• New data of golidocitinib with CHOP as first-line treatment show promising antitumor activity and a manageable safety profile. These findings support its potential as a frontline treatment option.
• Two real-world retrospective studies of golidocitinib in r/r cutaneous T-cell lymphoma (CTCL) and mycosis fungoides (MF) exhibit robust and durable antitumor activity with a manageable safety profile.
• A preliminary study evaluating golidocitinib combined with PD-1 blockade and asparaginase-containing immunochemotherapy demonstrates encouraging efficacy and a favorable tolerability profile for newly diagnosed and high risk advanced extranodal NK/T-cell lymphoma (ENKTL).

Birelentinib: in 1^st line CLL/SLL as a single agent and in combination with a BCL2 inhibitor

Birelentinib is an innovative dual inhibitor of Lyn and BTK, designed to simultaneously inhibit both BTK-dependent and BTK-independent B-cell receptor (BCR) signaling pathways. Two oral presentations will report data from birelentinib, as a monotherapy or in combination with venetoclax, in chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL).

• Birelentinib monotherapy has demonstrated robust antitumor activity, durable responses and favorable tolerability in patients with treatment-naïve and heavily pre-treated CLL/SLL. A global, randomized Phase 3 study is ongoing to compare the efficacy and safety of birelentinib versus investigator's choice of treatment in relapsed or refractory CLL/SLL.
• Birelentinib in combination with venetoclax in treatment-naïve CLL/SLL shows encouraging efficacy and a well-tolerated safety profile, regardless of high-risk genetic features.

GW5282: Preliminary Clinical Evaluation in r/r NHL

GW5282 is a next-generation EZH1/2 dual inhibitor designed to simultaneously inhibit both EZH1 and EZH2 with equal potency, thereby preventing the tumor escape due to compensatory activation of EZH1. GW5282 showed much improved drug-like properties, with high oral bioavailability, longer half-life, reasonable daily dose, and much improved bone marrow safety.

The emerging clinical data for GW5282 demonstrate an encouraging safety profile and clinical efficacy across multiple r/r non-Hodgkin lymphoma (NHL) subtypes.

Details of the respective presentations are summarized below:

About Golidocitinib

Golidocitinib is the world's first and only Janus kinase 1 (JAK1) inhibitor approved for the treatment of relapsed or refractory peripheral T-cell lymphoma (r/r PTCL). In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with r/r PTCL.

At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. All subtypes benefited well, and the ORR of common subtypes exceeded 40%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, the median duration of response (mDoR) reached 20.7 months. As of February 2024, golidocitinib showed a median overall survival (mOS) of 24.3 months.

Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) were published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) were published in The Lancet Oncology (Impact Factor: 54.4).

About Birelentinib

Two resistance mechanisms have been found in patients whose diseases have progressed on a BTK inhibitor treatment: the BTK C481X mutation and BTK-independent BCR signaling pathway activation. Birelentinib is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration, designed to treat both BTK-dependent and BTK-independent B-cell non-Hodgkin lymphoma (B-NHL).

In August 2025, birelentinib was granted Fast Track Designation by the U.S. FDA for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

About GW5282

GW5282 is a next-generation EZH1/2 (Enhancer of Zeste Homolog 1 and 2) dual inhibitor, preventing EZH1 compensatory activation as a resistance mechanism.

While EZH2 is a clinically validated target for multiple hematological and solid tumors, translational science evidence indicates that inhibiting EZH2 alone often leads to incomplete pathway blockade due to compensatory activation of EZH1. Furthermore, approved EZH2-only inhibitors are limited by a short plasma half-life. Consequently, much higher dosing regimens are required to cover the target, leading to high pill burden-related gastrointestinal adverse reactions and dose-limiting bone marrow toxicities.

GW5282 is designed to address these critical limitations. Available clinical data showed much improved drug-like properties, with high oral bioavailability, longer half-life, reasonable daily dose, and much improved bone marrow safety.

About Dizal

Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of oncology and hematological diseases. Dizal's late-stage portfolio includes two approved drugs and three investigational drugs in late-stage development. ZEGFROVY is approved in both the U.S. and China, for the treatment of NSCLC with EGFR exon20ins, with its worldwide development and commercialization rights licensed to AstraZeneca. Golidocitinib is approved in China for the treatment of relapsed and refractory peripheral T cell lymphoma. Birelentinib, a BBB-penetrant LYN/BTK dual inhibitor, is currently in pivotal studies for various hematological diseases. DZD6008, a 4^th generation EGFR TKI, and GW5282 are in post Proof-of-Concept studies. To learn more about Dizal, please visit www.dizalpharma.com, or follow us on LinkedIn or X.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", and "intend" and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal's competitive environment, and political, economic, legal, and social conditions.

Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

Contacts
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