YZYBIO-B (02496) announced on December 23, 2025, that its biosimilar drug Y225 has received Investigational New Drug (IND) approval from China's National Medical Products Administration (NMPA). Y225 is a biosimilar of the bispecific antibody Hemlibra® (emicizumab injection, targeting FIX and FX), used for treating hemophilia A.
Patients with hemophilia A suffer from congenital deficiency of coagulation factor VIII, leading to clotting disorders. Without intervention, bleeding episodes can result in severe complications or even death. Current treatments primarily involve prophylactic or post-bleeding administration of human blood-derived or recombinant factor VIII. However, over 20% of patients develop inhibitors against factor VIII, reducing treatment efficacy.
Hemlibra®, the originator drug, is the only bispecific antibody globally approved for prophylactic treatment in hemophilia A patients, regardless of inhibitor status. It offers advantages such as subcutaneous administration and dosing every four weeks. However, its high cost and strong patent protection—extending to 2038—limit accessibility. YZYBIO-B has independently innovated to overcome formulation patents, potentially enabling Y225 to launch seven years earlier than expected. If successful, Y225 could become China's first biosimilar of Hemlibra®, addressing the unmet need for high-barrier bispecific antibody biosimilars in the domestic market.
The approved clinical trial is a randomized, double-blind, single-dose, parallel-group study comparing the bioequivalence of Hemlibra® and Y225 in healthy male volunteers. The study will be led by Dr. Huang Chaolin, Director of Wuhan Jinyintan Hospital.
On June 17, 2025, YZYBIO-B entered a strategic partnership with Hubei Jiangxia Laboratory. The collaboration leverages Jiangxia Laboratory's research strengths in cutting-edge innovation and YZYBIO-B's expertise in antibody drug development and industrialization. Together, they will establish an antibody drug development and transformation center, focusing on innovative antibody design, efficient production processes, and clinical research. Y225 will be the first project under this partnership, accelerating R&D and commercialization efforts to enhance the company's pipeline efficiency and long-term industrial potential.