Wuhan, China  June 11, 2026  — Createrna announced that lanoracopan hydrochloride tablets (brand name: Yishining®), the company’s complement factor B (CFB) inhibitor, has received marketing approval from China’s National Medical Products Administration (NMPA) through the Priority Review and Approval pathway. The drug is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy.

This New Drug Application was granted Priority Review by the Center for Drug Evaluation (CDE), significantly shortening the review timeline and accelerating the availability of this innovative rare disease therapy for PNH patients in China.

A Historic Milestone

Lanoracopan hydrochloride tablets is a Class 1 innovative drug independently developed by Createrna and represents the first domestically developed oral complement factor B (CFB) inhibitor approved for marketing in China.

Pivotal Clinical Evidence

This approval is based on the world’s first head-to-head superiority-designed clinical trial comparing an oral CFB inhibitor against a targeted biologic in complement inhibitor-naïve PNH patients—a multicenter, randomized, open-label, active-controlled Phase III study evaluating the efficacy and safety of lanoracopan hydrochloride tablets versus eculizumab. 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 centers nationwide.

Key results demonstrated superiority over eculizumab:

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

    • Secondary Endpoints: Lanoracopan demonstrated clear superiority across secondary endpoints including anemia improvement, hemolysis control, transfusion independence, and quality of life enhancement.

    • Safety: Lanoracopan demonstrated favorable safety and tolerability with overall manageable risk.

The successful commercialization of lanoracopan hydrochloride tablets provides a new treatment option for Chinese PNH patients, alleviating symptoms, reducing the risk of critical complications, and addressing unmet clinical needs.

Mechanism of Action

Lanoracopan hydrochloride tablets bind to factor B (FB) in the alternative complement pathway, modulating C3 cleavage, downstream effector generation, and terminal pathway amplification. In PNH, the primary pathological mechanisms include intravascular hemolysis (IVH) mediated by the downstream membrane attack complex (MAC) and extravascular hemolysis (EVH) facilitated by C3b opsonization. Lanoracopan acts at the proximal level of the alternative pathway cascade, controlling both C3b-mediated EVH and terminal complement-mediated IVH.

About Paroxysmal Nocturnal Hemoglobinuria

PNH is a chronic, progressive, life-threatening rare hematologic disease clinically manifested by intravascular hemolysis, recurrent thrombosis, and bone marrow failure. Patients may also present with renal dysfunction, pulmonary hypertension, dysphagia, chest pain, abdominal pain, erectile dysfunction, and other multisystem complications that severely impact survival and quality of life.

In PNH patients with more severe baseline disease, lanoracopan elevated and maintained hemoglobin to normal levels, rapidly controlled hemolysis, effectively improved anemia symptoms, and achieved transfusion independence—thereby eliminating infection risks and transfusion-related reactions associated with chronic transfusion therapy.

Expanding Pipeline: IgA Nephropathy

Createrna is currently conducting a Phase II clinical trial of lanoracopan hydrochloride tablets in IgA nephropathy. At the 63rd European Renal Association Congress (ERA 2026) held on June 7, 2026, the company reported interim 12-week data: proteinuria target attainment reached 40%, with a urine protein-to-creatinine ratio (UPCR) reduction of 51.8%. These results were presented as a China Voice global debut at the ERA High-Impact Clinical Trials Symposium, attracting widespread attention.

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 committed to delivering advanced diagnostic and therapeutic solutions to patients through the discovery, development, and commercialization of innovative products, addressing significant unmet medical needs and advancing human health worldwide. Createrna maintains innovation as its core strategy with sustained high-intensity R&D investment, developing over 20 proprietary innovative drug pipelines across inflammatory/immune, respiratory, and cardiovascular therapeutic areas. Multiple candidates demonstrate high differentiation and leadership potential with First-in-Class/Best-in-Class (FIC/BIC) attributes.