Dizal to Present Hematology Portfolio Across T-cell and B-cell Lymphomas at ASH 2025

Golidocitinib: Expanding Treatment Options in T-Cell Lymphoma   Golidocitinib is a first-in-class Janus kinase 1 (JAK1) only inhibitor approved for relapsed/refractory peripheral T-cell lymphoma (r/r PTCL) in China, based on the results from the multinational pivotal study, JACKPOT8 Part B. Golidocitinib showed a confirmed ORR of 44.3% and a median overall survival (OS) of 24.3 months, significant improvement over currently available therapies.   At the ASH congress, Dizal will present new data highlighting the continued clinical development of Golidocitinib in PTCL:   R/R PTCL: Two-year follow-up of the JACKPOT8 Part B study from a U.S. center, showing consistent trend with the overall study results Synergistic effect in combination with chidamide, an HDAC inhibitor and potential mechanisms. Safety and efficacy of golidocitinib-based regimens in r/r PTCL-associated lymphohistiocytosis (HLH)   Newly diagnosed PTCL： Phase1/2 clinical trial and retrospective analysis indicated that golidocitinib in combination with CHOP demonstrated a manageable safety profile and encouraging antitumor activity in newly diagnosed PTCL. Study design of a Phase 2 study evaluating the safety and efficacy of golidocitinib in the management of newly diagnosed PTCL   Rare subtypes of PTCL： In a prospective clinical study, golidocitinib monotherapy demonstrated compelling clinical activity and a favorable safety profile in relapsed/refractory T cell and NK cell large granular lymphocyte leukemia (T/NK LGLL). Preliminary results from a phase 2 multicenter study demonstrated that golidocitinib combined with CHOP exhibited profound clinical activity in treatment-naïve monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL).   Birelentinib: Addressing treatment resistance in B-Cell Lymphoma   Birelentinib is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration. At the 2025 ASH Annual Meeting, Dizal will present extended follow-up results from its Phase 1/2 studies of birelentinib in chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) patients who have received prior treatment with covalent/non-covalent BTK inhibitors, BCL2 inhibitors, and BTK degraders. This study was featured as oral presentations at both the 2025 ASCO Annual Meeting and the 18th International Conference on Malignant Lymphoma (ICML). In August 2025, birelentinib received U.S. FDA Fast Track Designation for the treatment of relapsed/refractory (r/r) CLL/SLL.   Additionally, an ongoing phase 2 multicenter study (TAI-SHAN12) evaluating the efficacy and safety of birelentinib combination therapy in diffuse large B-cell lymphoma (DLBCL) will be published on the ASH abstracts site. Earlier data demonstrated that birelentinib monotherapy exhibited promising antitumor activity and a favorable safety profile in r/r DLBCL (EHA 2025, Poster PF962). Notably, comparable responses were observed in both GCB and non-GCB subtypes, differentiated from other reported BTKi. Preclinical data showed strong synergistic effects between birelentinib and other approved agents, supporting its potential to improve outcomes for patients with r/r DLBCL.   Dizal poster presentation details during 2025 ASH: Lead AuthorAbstract TitlePresentation Details Prof. Jianyong LiPhase 1/2 studies of DZD8586 in CLL/SLL patients after COVALENT and non-COVALENT BTK inhibitors and BTK degraders – extended follow-up report Publication Number: 3889 Poster Presentation December 7, 2025，6:00 PM - 8:00 PM Eastern time Prof. Luis MalpicaDurable responses in the updated 2-year follow-up of patients from a single-center with Relapsed/Refractory peripheral T-cell lymphoma treated with golidocitinib Publication Number: 5422 Poster - posted presentation December 8, 2025，6:00 PM - 8:00 PM Eastern time Prof. Luis MalpicaA Phase II, single-center, single-arm study evaluating the safety and efficacy of golidocitinib in the management of newly diagnosed PTCL (GOLDEN Study) Publication Number: 5434 Poster - posted presentation December 8, 2025，6:00 PM - 8:00 PM Eastern time Prof. Ting NiuEffects of golidocitinib and gecacitinib in mouse models of primary and secondary hemophagocytic lymphohistiocytosis Publication Number: 1215 Poster Presentation December 6, 2025，5:30 PM - 7:30 PM Eastern time Prof. Li LiMechanism of action of Golidocitinib on peripheral T-cell lymphoma: monotherapy and combination of Chidamide inhibit tumor proliferation and reverse the immune microenvironment Publication Number: 1778 Poster Presentation December 6, 2025，5:30 PM - 7:30 PM Eastern time Prof. Shuhua YiPreliminary efficacy and safety of golidocitinib in relapsed/refractory T cell and NK cell large granular lymphocyte leukemia Publication Number: 3648 Poster Presentation December 7, 2025，6:00 PM - 8:00 PM Eastern time Prof. Li WangGolidocitinib combined with CHOP in treatment-Naïve monomorphic epitheliotropic intestinal T-cell lymphoma: Preliminary results from a phase 2 multicenter, single-arm goal study Publication Number: 3649 Poster Presentation December 7, 2025，6:00 PM - 8:00 PM Eastern time Prof. Ting NiuDual anti-HLH and antitumor efficacy of golidocitinib in relapsed/refractory PTCL-associated hemophagocytic lymphohistiocytosis: A retrospective safety and activity analysis Publication Number: 6303 Poster Presentation December 8, 2025，6:00 PM - 8:00 PM Eastern time Prof. Wei ZhangGolidocitinib combined with CHOP in newly-diagnosed peripheral T-cell lymphoma: Preliminary Results from A phase 1/2 clinical trial Publication Number: 6322 Poster Presentation December 8, 2025，6:00 PM - 8:00 PM Eastern time Prof. Wenyu LiGolidocitinib combination therapy as first-line treatment in PTCL: Retrospective data from a single centre Publication Number: 6305 Poster Presentation December 8, 2025，6:00 PM - 8:00 PM Eastern time   About Golidocitinib (DZD4205) Golidocitinib is currently the first and only Janus kinase 1 (JAK1) inhibitor being evaluated for the treatment of 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 relapsed or refractory peripheral T-cell lymphoma (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 (DZD8586) 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 Dizal Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio. ZEGFROVY is the first and only small molecule drug approved in both the U.S. and China, for the treatment of non-small cell lung cancer with EGFR exon20 insertion mutations. Golidocitinib has been approved in China for the treatment of relapsed and refractory PTCL. 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 turnout to be incorrect.   Contacts Investor Relations: [email protected] Business Development: [email protected] Media Contact: [email protected]

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