YZYBIO-B (02496): Y225 (Emicizumab Injection) has obtained IND approval from the NMPA.

YZYBIO-B (02496) announced that on December 23, 2025, the Investigational New Drug (IND) application for its biosimilar drug Y225 has been approved by the National Medical Products Administration (NMPA) of the People's Republic of China. Y225 is a biosimilar drug of the bispecific antibody Emicizumab injection, used to treat hemophilia A. Patients with hemophilia A lack the intrinsic factor VIII, resulting in coagulation disorders. They are unable to stop bleeding on their own, which can lead to various adverse reactions and even death. In clinical practice, patients are typically treated with prophylactic or post-bleeding therapy using either human blood-derived or recombinant factor VIII. However, over 20% of patients develop factor VIII inhibitors, affecting the effectiveness of the treatment. Emicizumab, the bispecific drug, is the only one globally approved for prophylactic treatment of patients with or without factor VIII inhibitors and has advantages such as once every four weeks dosing and subcutaneous injection. However, its high cost makes it inaccessible to many patients. Emicizumab also has a high technological threshold and patent barrier, with registered patents extending the product protection until 2038. By innovatively surpassing the formulation patent of this patented product, Y225 is expected to be launched 7 years earlier and become the first biosimilar drug of Emicizumab approved domestically, filling the gap in the domestic market for high barrier bispecific antibody biosimilar drugs. The approved clinical trial is a randomized, double-blind, single-dose, parallel comparative study of the biological equivalence of Emicizumab to Y225 in healthy male subjects. The trial is led by Director Chaolin Huang of Wuhan Jinyintan Hospital. On June 17, 2025, the company signed a strategic cooperation agreement with the Jiangxia Laboratory in Hubei. The two parties will leverage the laboratory's research strengths in front-end innovation and the company's experience and platform capabilities in antibody drug development and industrialization to jointly build a center for the development and transformation of antibody drugs. The collaboration will focus on innovative antibody molecule design, efficient production process development, and clinical research. The Y225 project is the first batch of collaborative content, with ongoing progress in research and transformation to enhance the overall research and development efficiency and long-term industrialization potential of the company.