Zenitar Announces Initiation of International Randomized Study of Flonoltinib Maleate in Patients with Myelofibrosis and Related American Society of Hematology 2026 Meeting Presentations

Chengdu Zenitar Biomedical Technology Co., Ltd. (Zenitar) is developing flonoltinib maleate (FM), a first-in-class oral JAK2/FLT3/CDK6 inhibitor for myeloproliferative neoplasms (MPNs), including myelofibrosis (MF) and polycythemia vera (PV).

Zenitar launched randomized Phase 2 FM-MF-02 (NCT07750574) in the US, Canada and Brazil to select Phase 3 dose for JAKi-naïve and refractory MF. Randomized FMF-02 (NCT06457425) met its week-24 endpoints: superior SVR35 and TSS50 with FM 50/100mg versus ruxolitinib; previous data presented orally at ASH24 (#486) and ASH25 (#908). ASH 2026 presence covers FMF-02 long-term follow-up (oral presentation, #411, December 12, 4:30pm) and refractory PV Phase 2 data (poster, #3765, December 13, 6pm), both in Session 634.

“Over the 15 years since the initial FDA approval of Ruxolitinib, JAKi have markedly improved the prognosis of many patients with MF. The long-term data show significant room for improvement for this key therapeutic class in terms of both efficacy and tolerability” said Dr. Andrew Kuykendall, Moffitt Cancer Center and principal investigator of the FM-MF-02 study. “The initial data from the randomized FMF-02 study presented at the ASH meeting last year was very encouraging. The presentation on long-term follow up of this study at this year’s meeting is eagerly awaited. On the FM-MF-02 study, patients with MF and an inadequate response to prior JAKi are randomized to various FM regimens, including both of those (50mg/100mg) reported to be superior to Ruxolitinib in the FMF-02 study, and a third intermediate (75mg) dose. “This study will help define the best FM dosing regimen to take forward in registration studies of FM randomized against approved JAKi for patients with MF. I am very excited about leading it and to working closely with my colleagues on its conduct and generation of key data.”

"It is clear that JAK inhibitors have made a substantial difference in the quality and length of life of patients with MF. It is equally clear that there are significant limitations to the currently approved generation of JAKi” said Raajit Rampal, Director of the Myeloproliferative Neoplasms Program, Memorial Sloan Kettering Cancer Center. “Investigation of the biology of MF and of clinical resistance to JAKi in MF has identified several new candidate therapeutic targets in MF/MPN, including cyclin-dependent kinase 6 (CDK6). FM represents a novel drug that combines more specific targeting of JAK2 with CDK6 inhibition. FM-MF-02 is an important milestone study that demonstrates further proof-of-concept that this mechanism-based targeting can extend benefits to patients with MF beyond those observed with a first-generation JAKi such as ruxolitinib. FM is now well-positioned for pivotal registrational studies, and to potentially change currents standards of care."

“There are significant unmet needs for the majority of our patients with MF, the most important of which is the prospect of cure with tolerable therapies. This is a very exciting time for developmental therapeutics in MF as we have agents with diverse modes of action under clinical investigation. I expect JAKi to remain as a cornerstone of MF-therapy and thus the data generated on FM to date is particularly important,” said Claire Harrison, Professor of Myeloproliferative Neoplasms from Guy’s and St Thomas NHS Foundation Trust, and Chair of the FM Scientific Advisory Board. “We need next generation JAKi to further alter the disease course in MF. I found the initial report at to 2025 ASH meeting on the randomized FMF-02 study very intriguing with superiority to Ruxolitinib reported with both FM regimens across a meaningful clinical and molecular spectrum of patients with MF. The conduct of definitive regulatory studies of FM is an urgent necessity, and the FM-MF-02 study is a very important step on that path. Personally, I am very interested in moving rapidly to clinical studies of FM in combination with novel agents with non-JAKi modes of action for patients with MF and in the evolving data on FM for patients with advanced PV which will also be shared at the ASH meeting this year.”

“Our investigator’s satisfaction with the positive data from the prior FMF-02 randomized study of FM versus Ruxolitinib in patients with MF encouraged us to very rapidly advance to the international randomized FM-MF-02 study” said Professor Lijuan Chen, Zenitar Chairman, CEO & CSO. “FM’s clinical success as a highly selective JAK2 inhibitor with unique FLT3 and CDK6 inhibitory activity is very important for patients with MF who need substantial improvements in efficacy over that offered by first generation JAKi. As a FIC clinically important molecule FM validates the AI-driven, structure-based development programs that have generated Zenitar’s broad pipeline. We are excited to again share data on FM with the global community at the ASH meeting. Our expanding rapid conduct of registrational studies is key to getting our agents to patients in need and we are committed to the optimal conduct of these studies with our investigators around the world.”

About Zenitar

Zenitar is a late-stage biopharmaceutical company leveraging AI-driven structural biology to develop and commercialize novel therapeutics for malignant, cardiometabolic, neurodegenerative, and inflammatory diseases. For additional information, please visit the Company’s website at http://en.zenitar.com.cn

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