ZenFlonate (flonoltinib) / Zenitar Biomedical - LARVOL DELTA

Preliminary analysis of a phase 2b, randomized, active-control study of flonoltinib maleate (FM) vs. ruxolitinib in intermediate-2 or high-risk myelofibrosis patients (ASH 2025) - P1/2, P2 | "The updated results for the phase 2b of 75 MFpatients will be completed in December 2025. A pivotal phase III multicenter, randomized, positivecontrol, double blind clinical trial in China is currently in discussion with regulatory authority."

Clinical • P2b data • Fibrosis • Immunology • Myelofibrosis • Thrombocytopenia • CALR • CDK6 • FLT3 • TGFB1

Material Balance Study of [14C] Flonoltinib Maleate (ChiCTR) - P1 | N=6 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Soochow University

New P1 trial

Clinical Study on Drug Interactions of Flonoltinib Maleate Tablets (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd

New P1 trial

Study of Flonoltinib Maleate Tablets in the Treatment of Severe Novel Coronavirus (COVID-19) Infection (clinicaltrials.gov) - P=N/A | N=13 | Terminated | Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd | N=66 ➔ 13 | Active, not recruiting ➔ Terminated; the pandemic of COVID-19 was over.

Enrollment change • Trial termination • Infectious Disease • Novel Coronavirus Disease • IL6

Mass Balance Study of [14C] Flonoltinib Maleate (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd | Not yet recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Jul 2026 | Trial primary completion date: Oct 2026 ➔ Jul 2026

Trial completion • Trial completion date • Trial primary completion date

Study of Flonoltinib Maleate Tablets in the Treatment of Proliferative Bone Marrow Tumors (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Guizhou Bailing Group Pharmaceutical Co Ltd | N=31 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Hematological Malignancies • Myelofibrosis • Myeloproliferative Neoplasm • Oncology

A Phase II Clinical Trial of Flonoltinib Maleate Tablet in Intermediate-High Risk Myelofibrosis (clinicaltrials.gov) - P2 | N=75 | Active, not recruiting | Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2026 ➔ May 2027 | Trial primary completion date: May 2026 ➔ Nov 2025

Enrollment closed • Trial completion date • Trial primary completion date • Myelofibrosis

FM-MF-02: Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis (clinicaltrials.gov) - P2 | N=105 | Not yet recruiting | Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd

New P2 trial • Anemia • Hematological Disorders • Hematological Malignancies • Myelofibrosis • Myeloproliferative Neoplasm • Polycythemia Vera • Thrombocytosis

Material Balance Study of [14C] Flonoltinib Maleate (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd

New P1 trial

A Randomized, Open-label, Positive-controlled, Parallel-grouped, Multicenter Phase III Clinical Trial on the Efficacy and Safety of Flonoltinib Maleate Tablets in Patients With Intermediate- or High-risk Myelofibrosis (ChiCTR) - P3 | N=105 | Sponsor: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS);West China Hospital of Sichuan University; Chengdu

New P3 trial • Myelofibrosis

A Clinical Trial of Flonoltinib Maleate Tablets in the Treatment of JAK Inhibitor Refractory/Relapsed/Intolerant Patients With Medium to High Risk Myelofibrosis (clinicaltrials.gov) - P2 | N=64 | Recruiting | Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Myelofibrosis

Assessment of flonoltinib maleate versus ruxolitinib phosphate in intermediate- to high-risk myelofibrosis (FMF-02): study protocol for a multicenter, randomized, open-label phase IIB trial. (PubMed, Ther Adv Hematol) - P2 | "The FMF-02 trial is the first randomized phase IIb study directly comparing the novel inhibitor FM against RUX. Its findings are expected to generate pivotal evidence regarding whether FM offers superior or differentiated clinical benefits, thereby informing its potential as a frontline therapy for intermediate- to high-risk MF and guiding the design of future phase III studies."

Journal • P2b data • Chronic Eosinophilic Leukemia • Fibrosis • Hematological Disorders • Immunology • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • CDK6 • JAK2

Phase IIa Study on Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd | Active, not recruiting ➔ Recruiting

Enrollment open • Tumor mutational burden • Polycythemia Vera

A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis (clinicaltrials.gov) - P3 | N=105 | Recruiting | Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Myelofibrosis

A Clinical Trial of Flonoltinib Maleate Tablets in the Treatment of JAK Inhibitor Refractory/Relapsed/Intolerant Patients With Medium to High Risk Myelofibrosis (clinicaltrials.gov) - P2 | N=64 | Not yet recruiting | Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd

New P2 trial • Myelofibrosis

An open-label, positive drug-controlled, parallel-group, multicenter phase II clinical trial on the efficacy, safety and pharmacokinetics of flonoltinib maleate tablet in patients with intermediate and high-risk myelofibrosis (ChiCTR) - P2 | N=75 | Completed | Sponsor: Institute of Hematology, Chinese Academy of Medical Sciences / West China Hospital of Sichuan University; Chengdu Zenitar Biomedical Technology Co., L

New P2 trial • Myelofibrosis

Food Effect Study in Healthy Volunteers of Phase I Flonoltinib Maleate (ChiCTR) - P1 | N=24 | Completed | Sponsor: Chengdu Xinhua Hospital; Chengdu Zenitar Biomedical Technology Co.Ltd.

New P1 trial

Phase IIa study on the safety and efficacy of Flonoltinib Maleate Tablets in the treatment of patients with polycythemia vera (ChiCTR) - P2 | N=60 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS);West China Hospital of Sichuan University;Shengjin

New P2 trial • Polycythemia Vera

A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis (clinicaltrials.gov) - P3 | N=105 | Not yet recruiting | Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd

New P3 trial • Myelofibrosis

Phase IIa Study on Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd

New P2 trial • Tumor mutational burden • Polycythemia Vera

First-in-Human Phase I/IIa Safety and Efficacy of Flonoltinib Maleate, a New Generation of JAK2/FLT3 Inhibitor in Myelofibrosis (ASH 2024) - P1/2 | "FM may be a new treatment option for myelofibrosis pts. A randomized, open-label, positive-controlled, multicenter Phase II trial is currently underway in patients with moderate-risk myelofibrosis treated with FM."

Clinical • First-in-human • P1/2 data • Anemia • Cardiovascular • Fibrosis • Hypertension • Immunology • Infectious Disease • Leukopenia • Myelofibrosis • Myeloproliferative Neoplasm • Neutropenia • Pneumonia • Respiratory Diseases • Thrombocytopenia • Thrombocytosis • JAK1 • JAK2 • JAK3

Safety of Flonoltinib Maleate Tablets for the Treatment of Patients With Myeloproliferative (clinicaltrials.gov) - P1/2 | N=31 | Completed | Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Mar 2025

Trial completion • Trial completion date • Myelofibrosis • Myeloproliferative Neoplasm • Oncology

A Pharmacokinetic Study of the Food Effect on Flonoltinib Maleate Tablets (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd

New P1 trial

A Phase I Clinical Study of Flonoltinib Maleate Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd | Recruiting ➔ Completed

Trial completion

Another innovative drug of Zeling Biopharma has obtained FDA clinical trial approval, accelerating its global layout [Google translation] (bydrug.pharmcube.com) - "Recently, the innovative Class 1 chemical drug Flonoltinib Maleate Tablets (hereinafter referred to as 'Flonoltinib') developed by Chengdu Zeling Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as 'Zeling Bio') has obtained the clinical trial approval (IND) from the U.S. Food and Drug Administration (FDA), and has been approved to conduct Phase I/II clinical trials for the treatment of myeloproliferative neoplasms (MPN) in the United States."

IND • New P1/2 trial • Myeloproliferative Neoplasm