bezacitinib (OB756) / Biosun Pharma - LARVOL DELTA

Comparative Efficacy of Drug Therapies on Spleen Size and Symptom Reduction in Myelofibrosis: A Frequentist Network Meta-Analysis (SOHO 2026) - "Single-agent JAKis demonstrated variable efficacy similar to or worse than that of ruxolitinib, with an OR of 0.88 (95%CI:0.58–1.34) for momelotinib, 0.52 (95% CI, 0.05–6.05) for fedratinib, 0.35 (95% CI, 0.04–3.20) for bezacitinib, 0.17 (95% CI, 0.02–1.41) for jaktinib, and 0.16 (95% CI, 0.02–1.52) for pacritinib...Compared with BAT, pacritinib showed an OR of 3.43 (95% CI, 0.39–29.76), navtemadlin 3.26 (95% CI, 0.92–11.53), and momelotinib 3.10 (95% CI, 1.13–8.53)... In JAKi-naïve myelofibrosis, combination strategies with navitoclax or pelabresib added to ruxolitinib demonstrated the greatest spleen responses. Ruxolitinib remains similar or superior to single-agent JAKis in spleen or symptom response. In ruxolitinib-exposed patients with myelofibrosis, fedratinib, momelotinib, and pacritinib showed clinically meaningful activity compared with BAT, and fedratinib was numerically better than others."

Retrospective data • Myelofibrosis • Oncology

A NOVEL JAK2 INHIBITOR OB756 FOR POLYCYTHEMIA VERA WITH SPLENOMEGALY: A PHASE IB/II, MULTICENTER STUDY (EHA 2026) - P | "Eligible patients aged ≥ 18 years with polycythemia vera (PV) with splenomegaly intolerant or resistant to hydroxyurea or interferon were enrolled in this study. Acknowledgement: This research was supported by the National Natural Science Foundation of China (No. 82570191) and the Zhejiang Provincial Health Highlevel Innovative Talent Project (2022-2026)."

Clinical • P1/2 data • Hematological Disorders • Myeloproliferative Neoplasm • Polycythemia Vera • Thrombocytopenia

Bezacitinib Tablet Compared with Best Available Therapy for the Treatment of Polycythemia Vera Resistant or Intolerant to Hydroxyurea (BEWELL-302): An Open-Label, Randomized, Controlled, Multicenter, Phase 3 Study (ChiCTR) - P3 | N=104 | Completed | Sponsor: The First Affiliated Hospital of Zhejiang University School of Medicine; Hangzhou Bangshun Pharmaceutical Co., Ltd.

New P3 trial • Tumor mutational burden • Polycythemia Vera

OB756, A NOVEL SELECTIVE JAK2 INHIBITOR, IN PATIENTS WITH MYELOFIBROSIS AND BASELINE THROMBOCYTOPENIA (<100×10⁹/L), ANEMIA (<100 G/L), AND MASSIVE SPLENOMEGALY: AN EXPLORATORY ANALYSIS (EHA 2026) - "In summary, OB756 demonstrated favorable tolerability and significant clinical efficacy in intermediate- to high-risk MF patients with severe cytopenia and massive splenomegaly, particularly showing outstanding efficacy in rapidly reducing spleen volume, with low incidence of non-hematologic toxicities. This study provides a new treatment option for MF patients with poor baseline characteristics. This research was supported by the National Natural Science Foundation of China (No."

Clinical • Anemia • Infectious Disease • Myelofibrosis • Myeloproliferative Neoplasm • Thrombocytopenia • Thrombocytosis

Indirect treatment comparison of novel JAK2 Inhibitor OB756 versus ruxolitinib in polycythaemia vera with splenomegaly (ASH 2025) - "Overall, OB756 appears to show potential benefits in efficacy and safety in PV patients with splenomegaly compared to ruxolitinib in preliminary analyses of RESPONSE-1 study. These findings suggest that OB756 may offer advantages in reducing both hematological AEs such as anemia, thrombocytopenia, lymphopenia, neutropenia, and non-hematological AEs in JAK inhibitor-naïve PV patients with splenomegaly. However, these observations require confirmation through direct head-to-head studies."

Leukopenia • Neutropenia • Polycythemia Vera • Pulmonary Disease • Thrombocytopenia

Efficacy and safety of OB756 (a Novel Selective JAK2 Inhibitor) for essential thrombocythemia in patients intolerant or resistant to hydroxyurea or interferon: A phase II, open-label, multicenter study (ASH 2025) - "In summary, OB756 demonstrated favourable tolerability and marked clinical efficacy inpatients with ET who were resistant to or intolerant of hydroxyurea or interferon. The agent rapidlyinduced haematologic responses, reduced spleen volume, and lowered JAK2 V617F allelic burden.Sustained complete haematologic responses were maintained, and non-haematologic toxicities wereinfrequent, positioning OB756 as a highly promising new therapeutic option for ET patients who areresistant to or intolerant of hydroxyurea or interferon.Acknowledgement: This research was funded by the Zhejiang Provincial Health High-level InnovativeTalent Project (2022-2026). *Correspondence to: Prof Jian Huang, E-mail:[email protected]"

Clinical • P2 data • Essential Thrombocythemia • Infectious Disease • Myeloproliferative Neoplasm • Neutropenia • Thrombocytosis

A Novel JAK2 Inhibitor OB756 Inhibits Megakaryopoiesis Differentiation and Proplatelet Biogenesis in Thrombocythemia and Polycythemia Vera (ASH 2024) - "2022ZYC-D09). *Correspondence to : Prof Jian Huang, E-mail : [email protected]."

Hematological Disorders • Myeloproliferative Neoplasm • Oncology • Polycythemia Vera • Thrombocytopenia • Thrombocytosis • CD34 • ITGA2B • ITGB3

First in-Class JAK2 Inhibitor OB756 Therapy for Patients with Polycythemia Vera : A Phase 2, Open-Label, Multicenter Study (ASH 2024) - "OB756 also showed durable CHR and few non-hematological TEAEs, and may be a new treatment option for PV patients. Furthermore, a randomized double-blind phase 3 study is ongoing, aiming to assess the efficacy and safety of OB756 compared to hydroxyurea in patients with PV in China (CTR20240873)."

Clinical • P2 data • Anemia • Cardiovascular • Myeloproliferative Neoplasm • Polycythemia Vera • Thrombocytopenia • Thrombosis

A Novel JAK2 Inhibitor OB756 in Treatment of Janus Kinase Inhibitor-Naive Patients with Myelofibrosis: A Phase 1/2, Open-Label, Multicenter Study (ASH 2024) - "Conclusion : OB756 is well tolerated and showed meaningful clinical activity in patients with MF, especially for quick and durable spleen reduction. OB756 also showed few non-hematological TEAEs, and may be a new treatment option for MF patients."

Clinical • P1/2 data • Anemia • Myelofibrosis • Thrombocytopenia • CALR

Efficacy and safety of OB756 (a novel selective JAK2 inhibitor) for essential thrombocythemia in patients intolerant of or resistant to hydroxyurea or intolerant of interferon: A phase 2, open-label, multicenter study. (PubMed, Cancer) - "Overall, OB756 was well-tolerated and demonstrated acceptable efficacy, offering a promising therapeutic option for ET patients who are resistant to or intolerant of hydroxyurea or intolerant of interferon."

Clinical • Journal • P2 data • Essential Thrombocythemia • Hematological Disorders • Infectious Disease • Myeloproliferative Neoplasm • Neutropenia • Oncology • Thrombocytosis

Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of OB756 Tablets in Patients with Intermediate/High-Risk Myelofibrosis, Polycythemia Vera, and Essential Thrombocythemia (ChiCTR) - P1/2 | N=236 | Completed | Sponsor: The First Affiliated Hospital of Zhejiang University School of Medicine; Hangzhou Biosun Pharmaceutical Co., LTD

New P1/2 trial • Tumor mutational burden • Hematological Disorders • Myelofibrosis • Myeloproliferative Neoplasm • Polycythemia Vera • Thrombocytosis

A PHASE 2, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY AND EFFICACY OF OB756, A NOVEL JAK2 INHIBITOR, IN JAK INHIBITOR-NAÏVE PATIENTS WITH ESSENTIAL THROMBOCYTHEMIA (EHA 2025) - P1/2 | "Essential thrombocythemia (ET) has a relatively favorable prognosis among MPNs, but it still carries a heavy disease burden, and many patients are intolerant to hydroxyurea or interferon therapy. OB756 shows good tolerability and efficacy in ET patients, rapidly achieving hematologic remission, reducing spleen size, and lowering JAK2V617F allele burden, with durable responses and low non-hematologic toxicity, emerging as a promising new treatment option."

Clinical • P2 data • Anemia • Essential Thrombocythemia • Gene Therapies • Leukopenia • Myeloproliferative Neoplasm • Thrombocytopenia • Thrombocytosis

A NOVEL JAK2 INHIBITOR OB756 INHIBITS MEGAKARYOPOIESIS DIFFERENTIATION AND PROPLATELET BIOGENESIS VIA PI3K-AKT SIGNALING PATHWAY IN PATIENTS WITH PH-NEGATIVE MYELOPROLIFERATIVE NEOPLASMS (EHA 2025) - "The novel JAK2 inhibitor OB756 inhibits MKs differentiation, ploidy, and platelet biogenesis via PI3K-AKT signaling pathway in Ph- MPNs, highlighting its potential clinical benefits for MPN patients."

Clinical • Essential Thrombocythemia • Hematological Disorders • Myeloproliferative Neoplasm • Oncology • Polycythemia Vera • Thrombocytopenia • Thrombocytosis • CD34 • ITGA2B • ITGB3

OB756 Showcases Favorable Tolerability in JAK Inhibitor–Naive Myelofibrosis (OncLive) - P1b/2 | N=85 | CTR20201950 | "The investigative JAK2 inhibitor OB756 was found to be well tolerated and to elicit meaningful clinical activity in the form of rapid and durable spleen reduction in Chinese patients with myelofibrosis who did not have prior exposure to JAK inhibition, according to data from a phase 1/2 study (CTR20201950) presented during the 2024 ASH Annual Meeting. In the phase 1 portion of the research, no dose-limiting toxicities were reported when the agent was administered at twice daily doses ranging from 8 mg to 32 mg. Investigators ultimately identified 16 mg and 20 mg twice daily as the recommended phase 2 dose (RP2D) according to p-STAT3 inhibited percentage in an Imax model. Of 66 evaluable patients, 54.5% achieved a spleen volume reduction (SVR) of at least 35% (SVR35) at the end of cycle 6. Moreover, 59.1% of patients achieved SVR35 at the time of the last follow-up; at the end of cycle 12, 50.0% had achieved SVR35."

P1/2 data • Myelofibrosis

Phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and initial efficacy of OB756 tablets in moderate to high-risk patients with primary myelofibrosis, postcytoplasmic myelofibrosis, and postthrombocythemia primary myelofibrosis (ChiCTR) - P1/2 | N=120 | Completed | Sponsor: The First Affiliated Hospital of Zhejiang University School of Medicine; Hangzhou Biosun Pharmaceutical Co., LTD

New P1/2 trial • Hematological Disorders • Myelofibrosis • Polycythemia Vera • Thrombocytosis