Recently, Chengdu Zeling Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as "Zeling Bio") announced that its independently developed core product, Flunotinib Maleate Tablets (FM), has been officially included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of the National Medical Products Administration . The proposed indication is BCR-ABL fusion gene (Ph) negative myeloproliferative neoplasms (MPN), including myelofibrosis (MF), polycythemia vera (PV), and essential thrombocythemia (ET).

BTD demonstrates clinical value and accelerates drug development.

The Breakthrough Therapy Program (BTD) is a special review pathway established by the National Medical Products Administration (NMPA) to accelerate the research and development and market launch of innovative drugs with significant clinical advantages. It aims to expedite the development of innovative drugs for the prevention and treatment of serious life-threatening or life-threatening conditions for which there are currently no effective treatments or which offer significant clinical advantages compared to existing therapies. FM's successful inclusion in the BTD signifies that it has demonstrated significant therapeutic potential in clinical trials targeting this indication.

With inclusion in the Breakthrough Therapy Designation (BTD) framework, Zeling Biotech can engage in more frequent and efficient communication with the Center for Drug Evaluation (CDE) regarding the development of flunotinib maleate tablets (e.g., submitting applications for Class I communication meetings), thereby exploring more flexible clinical development strategies and accelerating the drug's market launch. According to incomplete statistics, using the review time of 19 non-breakthrough therapy Class 1 new drugs approved for marketing in 2021 as a comparison, the median time from IND submission to NDA submission for non-breakthrough therapy Class 1 new drugs (non-BTD) was 7.23 years, while for Breakthrough Therapy (BTD) it was 4.12 years; the technical review time for non-BTD marketing applications was 402 days, while for BTD it was 253 days; as of January 23, 2026, 405 drugs/indications in China have been included in the Breakthrough Therapy designation, with no cases of withdrawal or termination of marketing approval. Through policy support and resource allocation, FM will significantly shorten the cycle from R&D to market launch for innovative drugs, enabling patients to access breakthrough treatment options for their indications earlier.

Recognized by both China and the United States, this marks a significant step forward in China's global expansion strategy.

It is worth noting that this BTD designation from China's National Medical Products Administration (NMPA) is another significant regulatory milestone for FM. Previously, the product had received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of myelofibrosis (MF).

Flunotinib maleate tablets, a drug with the potential to change the global landscape of myeloproliferative neoplasm treatment, have received dual authoritative recognition as an orphan drug in the United States and a breakthrough therapy in China. This not only fully demonstrates FM's outstanding clinical advantages and huge medical needs, but also lays a solid foundation for the future global development and commercialization of the product.

About Flunotinib Maleate (FM)

FM is a new generation of highly selective JAK2 inhibitor independently developed by Zeling Biotechnology that simultaneously targets the JAK2 pseudokinase-binding domain JH2 and the JAK2 kinase-binding domain JH1. Through synergistic inhibition of FLT3 and CDK6, it maintains spleen shrinkage and symptom improvement while improving bone marrow fibrosis, making it a novel JAK2/CDK6/FLT3 tri-target inhibitor.

At the 2025 ASH Annual Meeting, Zeling Biotech presented the latest topline data from the Phase IIb head-to-head study of FM in intermediate/high-risk myelofibrosis via oral presentation: Compared with first-line standard treatment ruxolitinib, FM showed a higher proportion of patients achieving the internationally recognized dual endpoints at week 24, demonstrating a statistically significant advantage. Specifically, the high-dose group showed a significant improvement in the primary endpoint SVR35 compared to the control group (p=0.009), and a significant improvement in the key secondary endpoint TSS50 (p<0.001). Furthermore, 96.2% (25/26) of patients achieved both endpoints, and positive improvements in bone marrow pathology were observed. Simultaneously, FM also demonstrated positive spleen reduction and symptom improvement in patient populations with poor prognoses from existing JAK inhibitors (such as those with low platelet counts and CALR mutations), filling an unmet clinical need in current myelofibrosis treatment.

Currently, a Phase III clinical trial of FM versus ruxolitinib as first-line treatment for intermediate/high-risk myelofibrosis, a Phase II clinical trial as second-line treatment for intermediate/high-risk myelofibrosis, and a Phase II clinical trial for the treatment of polycythemia vera (PV) have been initiated.
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