Tomoshibayu Biological-B (02496): Phase I clinical trial of Y225 to treat haemophilia A completed first patient administration

According to the Zhitong Finance App, Youzhiyou Bio-B (02496) announced that the company has completed the first patient administration in a phase I clinical study of Y225, an antibiosimilar drug currently being developed by the company in China. ^{This phase I clinical trial is a randomized, double-blind, single-dose, parallel comparison study. The aim is to evaluate the bioequivalence between Y225 and the reference drug Shuyoulilac® (emicerizumab injection) in healthy male subjects, and to provide a basis for subsequent clinical development of Y225.} This marks the entry of the project into the human clinical research phase.

^{Y225 is a bispecific antibody candidate developed by our company in accordance with biosimilar research and development requirements using Shuyulile® as a reference drug. It is intended to be used for the prevention and treatment of hemophilia A.} By bridging coagulation factor IX (FixA) and coagulation factor X (FX), emixizumab simulates the function of some cofactors that activate coagulation factor VIII. The original drug has been approved in China for routine preventive treatment of adults and children with hemophilia A with coagulation factor VIII inhibitors, and for adults and children with severe hemophilia A without this inhibitor. It is injected subcutaneously, and the maintenance period can be selected as a weekly, every two weeks, or every four weeks according to the doctor's instructions.

Hemophilia A is a hereditary hemorrhagic disease. Patients face the risk of repeated bleeding and joint damage due to lack of coagulation factor VIII or insufficient function. Long-term regular prevention and treatment is important. According to public information, as of February 2025, China had completed the registration of 53,177 cases of hemophilia; an expert interview published in June 2026 further revealed that the National Hemophilia Case Information Management System had registered more than 60,000 patients as of 2025. The above data is the total number of registered patients with different types of hemophilia. The increase in the number of registered patients further highlights the need to standardize diagnosis and treatment in the long term and improve the accessibility of treatment.

The company promotes the development of Y225 with the aim of expanding treatment options for patients with hemophilia A and creating conditions to improve the accessibility and affordability of long-term preventive treatment. The company's Y225 related antibody formulation technology has been authorized by a Chinese patent, and will steadily advance follow-up research and evaluation work in accordance with biosimilar research and development requirements.

On June 17, 2025, the company signed a strategic cooperation agreement with Hubei Jiangxia Laboratory to jointly build an antibody drug development and achievement transformation center. Y225 is one of the first cooperation projects between the two parties. The two sides will continue to promote related R&D and transformation of results by combining their respective scientific research resources, antibody drug research and industrialization capabilities.