YZY Biopharma Y225 Patent Secures Hemlibra Biosimilar Pathway in China

Wuhan YZY Biopharma Co., Ltd. (HKG: 2496) announced today that its high‑concentration antibody formulation for the biosimilar Y225—a therapeutic equivalent to Roche’s Hemlibra (emicizumab)—has been granted an invention patent in China. The patent (No. ZL 202510126091.1) was approved by the National Intellectual Property Administration (CNIPA) under a prioritized examination, with the authorization publication (CN 119950703B) issued on 28 Oct 2025.

Patent Highlights

• Scope – Covers the antibody formulation technology that enables a high‑concentration, subcutaneous dosing regimen identical to Hemlibra.
• Strategic Value – Breaks through the existing formulation patent held by Roche (expiring 2037) and allows Y225 to enter the Chinese market up to six years before the originator’s patent expiry.
• Application – Filed on 27 Jan 2025; granted after expedited review, underscoring the urgency of addressing unmet needs in hemophilia care.

Y225 – A Game‑Changing Hemophilia A Therapy

• Mechanism – A bispecific antibody that mimics coagulation Factor VIII, restoring clotting ability in patients with or without Factor VIII inhibitors.
• Clinical Advantage – Once‑every‑four‑week dosing with subcutaneous injection mirrors Hemlibra’s convenience, yet the new formulation removes the high‑concentration barrier that has limited biosimilar development.
• Regulatory Status – Y225’s Investigational New Drug (IND) application has been accepted by the National Medical Products Administration (NMPA) (Acceptance Nos.: CXSL2500899, CXSL2500897).

Market Impact

• Early Access – The patent breakthrough positions Y225 to launch in China as early as 2029, potentially delivering a cost‑effective alternative to the > USD 5 billion global Hemlibra sales in 2024.
• Patient Reach – By overcoming formulation restrictions, Y225 could dramatically expand treatment options for hemophilia A patients across China, where the prevalence of the disease and the need for affordable therapies remain high.

Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech