Wuhan, China  February 13, 2026

 Wuhan Createrna Science and Technology Development Co., Ltd. announced that MY008211A Tablets, its independently developed oral small-molecule complement factor B (CFB) inhibitor, has successfully met the primary efficacy endpoint in the Phase III clinical trial (MY008211A-PNH-3-02) evaluating the drug in paroxysmal nocturnal hemoglobinuria (PNH) patients who have not previously received complement inhibitor therapy.

The study was co-led by Professor Zhang Fengkui of the Tianjin Institute of Hematology and Professor Han Bing of Peking Union Medical College Hospital, with participation from seven PNH medical centers across China.

Key Efficacy Results

Results demonstrated that MY008211A Tablets achieved superiority over the active comparator eculizumab on both the primary endpoint and multiple secondary endpoints:

    • Hemoglobin Normalization: 50.0% of subjects in the MY008211A group achieved normal hemoglobin levels (Hb ≥120 g/L), significantly superior to 9.1% in the eculizumab group.

    • Secondary Endpoints: MY008211A Tablets demonstrated superior efficacy across secondary endpoints including improvement of anemia, hemolysis control, transfusion independence, and         quality of life improvement.

    • Safety: MY008211A Tablets demonstrated favorable safety and tolerability with an overall manageable risk profile.

Clinical Significance

Hemoglobin improvement remains the core therapeutic goal for PNH patients. Under current available treatments, a substantial proportion of patients fail to achieve normal hemoglobin levels. In this study, MY008211A Tablets elevated and maintained hemoglobin to normal levels in PNH patients with more severe baseline disease compared to similar Phase III studies of other agents in this class, rapidly controlled hemolysis, effectively improved anemia symptoms, and achieved transfusion independence—thereby avoiding infection risks and transfusion-related reactions. Additionally, MY008211A Tablets offer the convenience of oral administration.

Safety Profile

Phase III safety analysis confirmed favorable safety and tolerability with overall manageable risk. During the trial period, the majority of adverse events and drug-related adverse events were Grade 1–2. No meningococcal infections were observed, and breakthrough hemolysis risk remained controlled.

Management Commentary

Chen Yongkai, Senior Vice President of Createrna, stated: "The Phase III results for MY008211A Tablets demonstrate significant efficacy advantages in PNH patients, particularly in hemoglobin normalization—the primary endpoint. After 24 weeks of treatment, 50.0% of subjects in the MY008211A group achieved Hb ≥120 g/L, significantly surpassing the 9.1% rate in the eculizumab group. Additionally, subgroup analyses suggest that even PNH patients with more severe baseline disease achieved high rates of hemoglobin normalization following MY008211A treatment. These findings offer a potentially transformative new option for PNH treatment and further validate the outstanding clinical development value of MY008211A in hematologic diseases."

Zhou Xunan, Head of Medical Strategy and Affairs at Createrna, added: "PNH patients currently face significant unmet needs including difficulty achieving hemoglobin normalization and transfusion dependence. While C5 monoclonal antibodies provide partial hemolysis control, many patients still cannot achieve hemoglobin normalization. As an oral small-molecule CFB inhibitor, MY008211A targets a key upstream node of the alternative complement pathway, enabling earlier and more complete blockade of complement overactivation compared to C5 antibodies—which is the fundamental basis for its demonstrated superiority in hemoglobin normalization. We are confident that this drug will bring PNH patients a transformative option combining high efficacy with safety, and we will accelerate its clinical development and commercialization to benefit PNH patients in China and globally."

About the MY008211A-PNH-3-02 Study

MY008211A-PNH-3-02 is a multicenter, active-comparator, parallel-group clinical study evaluating the efficacy of MY008211A Tablets versus eculizumab in PNH patients naïve to complement inhibitor therapy. The study employed a randomized, open-label design in which eligible subjects were randomized 1:1 to receive either oral MY008211A Tablets (400 mg BID) or intravenous eculizumab for a 24-week treatment period. A total of 67 complement inhibitor-naïve PNH patients were enrolled across 7 sites in China. Additional trial information is available at the clinical trial registry (CTR20242848).

About MY008211A Tablets (Lanoracopan Hydrochloride Tablets)

Yishining® (generic name: lanoracopan hydrochloride tablets), discovered and developed by Createrna scientists, is a CFB inhibitor currently being investigated for multiple complement-mediated hemolytic diseases. In vitro mechanistic studies show that Yishining® binds to CFB and effectively inhibits complement pathway activation, thereby suppressing hemolysis. Lanoracopan hydrochloride tablets (Yishining®) are currently in a Phase II clinical trial for IgA nephropathy. Clinical development for additional complement-mediated diseases is in preparation.

About Createrna

Wuhan Createrna Science and Technology Development Co., Ltd. is a research-driven, commercial-stage innovative biotechnology company headquartered in Wuhan, China. The company is dedicated to addressing significant unmet medical needs in autoimmune diseases and cardiovascular/cerebrovascular diseases through the discovery, development, and commercialization of innovative products. Createrna’s mission is to leverage its capabilities and resources to advance human health and well-being in China and worldwide.