Zelun BioPharma Initiates Phase IIa Clinical Trial of Flonoltinib Maleate Tablets for Polycythemia Vera

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that Zenitar's Phase IIa clinical trial has been initiated to evaluate the safety, efficacy, and pharmacokinetics of Flunotinib Maleate Tablets in treating polycythemia vera patients who are resistant or intolerant to hydroxyurea or interferon. The trial is open-label, randomized, parallel-controlled, and multi-center. The clinical trial registration number is CTR20253643, with the initial information disclosure date on September 10, 2025.

The drug is in tablet form, administered orally, with three dosage strengths: 75mg, 100mg, and 125mg, all with a treatment duration of 52 weeks. The primary objective of the dose exploration phase in this trial is to evaluate the safety of Zenitar's flunotinib maleate tablets for treating PV patients and to determine the dose for the expansion phase. The main purpose of the dose expansion phase is to assess its efficacy in treating PV patients.

Flunotinib Maleate Tablets are a chemical drug indicated for polycythemia vera. This is a clonal chronic myeloproliferative disease of hematopoietic stem cells, characterized by an abnormal increase in red blood cells, which can cause symptoms such as headache, dizziness, and skin itching. Diagnosis relies on tests such as blood count and bone marrow aspiration.

The primary endpoint of this trial includes the proportion of subjects achieving HCT control at the end of 28 weeks of treatment; secondary endpoints include the proportion of subjects achieving HCT control at the end of 16, 40, and 52 weeks of treatment, among other indicators.

Currently, the experiment status is ongoing (not yet recruiting), with a target enrollment of 60 participants.

Risk Warning: The market involves risks, and investments should be made with caution. This article is automatically published by an AI model based on a third-party database. Any information appearing in this article (including but not limited to individual stock recommendations, comments, forecasts, charts, indicators, theories, or any form of expression, etc.) is for reference only and does not constitute personal investment advice. Due to limitations such as the quality of the third-party database, we are unable to verify or ensure the authenticity and completeness of the data. Therefore, the content of this article may contain inaccuracies, incompleteness, or misleading information. Please refer to official company announcements for specifics. If you have any questions, please contact biz@staff.sina.com.cn.

Editor: Xiaolang Express