Polycythemia Vera Clinical Trials

⁃ Male and female subjects aged 18-75 years (inclusive);

⁃ Subjects diagnosed with polycythemia vera (PV) according to the 2016 world health organization (WHO) criteria;

⁃ Hydroxyurea-resistant/intolerant and/or interferon α-resistant/intolerant:

• Hydroxyurea-resistant or -intolerant Must meet the definition of hydroxyurea (HU) resistance or intolerance in the 2024 chinese society of clinical oncology (CSCO) Guidelines for the diagnosis and treatment of malignant hematological diseases and satisfy at least one of the following criteria:a) Resistance: Despite ≥3 months of HU treatment at a dose of ≥2 g/d, phlebotomy is still required to maintain HCT \<45%; after ≥3 months of HU treatment at a dose of ≥2 g/d, bone marrow proliferation remains uncontrolled (e.g., platelets \>400×10⁹/L and WBC \>10×10⁹/L); after ≥3 months of HU treatment at a dose of ≥2 g/d, a palpable massive splenomegaly fails to reduce by \>50% or splenomegaly-related clinical symptoms do not fully resolve;b) Intolerance: At the minimum hydroxyurea (HU) dose required to achieve a complete or partial clinical hematologic response for the disease, absolute neutrophil count (ANC) \<1.0×10⁹/L or PLT count \<100×10⁹/L or Hemoglobin (HGB) \<100 g/L occurs; during HU treatment at any dose, lower extremity ulcers or other intolerable non-hematological toxicities emerge, such as skin and mucous membrane manifestations (skin, teeth, or nail darkening; oral ulcers, mucositis; skin ulcers, rash, etc.), gastrointestinal symptoms (nausea, anorexia, indigestion, vomiting, abdominal pain, constipation, etc.), pneumonia, fever, etc.; 2)Interferon α-resistant or -intolerant Must satisfy at least one of the following criteria:a) Resistance: After achieving at least 12 weeks of interferon α therapy and a dose of at least 25×10⁶ U/week (or the subject's maximum tolerated dose if it is less than 25×10⁶ U/week), phlebotomy is still required to maintain HCT \<45%, or PLT \>400×10⁹/L and WBC \>10×10⁹/L, or palpable splenomegaly (starting \>10 cm from the left costal margin) fails to reduce by \>50%;b) Intolerance: At the minimum interferon α dose required for complete or partial clinical hematologic remission, ANC \<1.0×10⁹ or PLT \<100×10⁹ or hemoglobin \<100 g/L (\<10 g/dL) occurs, or depression, influenza-like symptoms, neuropsychiatric symptoms, autoimmune issues, or other unacceptable non-hematological toxicities related to interferon-alpha (IFN-α) emerge, defined as common terminology criteria for adverse events (CTCAE) V5.0 grade 3-4 events, or CTCAE V5.0 grade 2 events lasting over 1 week, or permanent discontinuation of interferon α, or interruption of interferon α until toxicity resolves, or hospitalization due to interferon α toxicity.

• The subject has intact skin at the injection site, and the investigator deems it is suitable for subcutaneous injection; 5.Eastern cooperative oncology group (ECOG) performance status score is 0, 1, or 2; 6.The subject has undergone bone marrow biopsy within 12 months prior to enrollment; 7.The subject or the subject's legal guardian has signed a written informed consent, and the subject is able to comply with the study requirements.