On September 21, 2023, the investigator meeting for the project "An Open-label, Multi-center Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in Children with Severe Hemophilia A" sponsored by Jiangsu Gensciences Inc. (Jiangsu Gensciences) was successfully held in Quanzhou, Fujian, marking the formal initiation of the Phase III clinical trial of FRSW107 in pediatric patients with severe hemophilia A under the age of 12.

The leading unit, Beijing Children`s Hospital affiliated to Capital Medical University, participated in this investigator meeting together with 13 other study sites, where a number of experts put forward suggestions on the smooth implementation of the clinical trial and actively participated in the discussion. The principal investigator Prof. Wu Runhui from Beijing Children's Hospital of Capital Medical University pointed out that the recombinant human coagulation factor VIII-Fc fusion protein for injection (FRSW107) is the first domestic long-acting recombinant coagulation factor VIII product, and the results of Phase I clinical trial in children showed that, at a dose of 50 IU/kg, no bleeding was observed in the subjects within 72 h, and the trough concentration was maintained at 1% and above, and that prophylactic dosing once every 3 days in Phase III trial is clinically important in reducing bleeding and reducing venous load in pediatric patients. It is believed that the successful conduct of this clinical trial and the approval of the pediatric indication will bring hemophilia specialists, pediatric patients and their families a hemophilia drug option with better efficacy and better compliance.

Hemophilia is a bleeding disorder caused by deficiency in blood coagulation factors, including Hemophilia A (FⅧ deficiency) and Hemophilia B (FⅨ deficiency). It is inherited in an X-linked recessive pattern, transmitted by females, and develops in males; female patients are extremely rare. It is clinically manifested as bleeding and hematoma compression symptoms, and is mainly treated by administering coagulation factor VIII-containing preparations, such as fresh whole blood, fresh plasma, cold precipitates, and coagulation factor preparations, as well as  non-factor therapies or physical therapies, at regular intervals or when necessary.

Recombinant human coagulation factor VIII-Fc fusion protein for injection (FRSW107) is independently developed by Jiangsu Gensciences with a unique patented structure design, FRSW107 can effectively extend the half-life and allow dosing once every 3 days or twice a week. "FRSW107 product" is developed based on the "two-headed homodimer Fc fusion technology". The fusion protein of BDD (B-domain deleted) recombinant human coagulation factor VIII and human IgG2 subtype Fc fragment improves the half-life of FVIII, and has the advantages of multinational patents, long-term efficacy in vivo, high protein stability and low production cost. 

FRSW107 developed by Jiangsu Gensciences effectively decreases the frequency of drug use, reduces the duration and pain of drug injections for hemophilia A patients, while maintaining a higher FVIII level in vivo for a longer period of time, and greatly reducing spontaneous bleeds to significantly improve the quality of life for the patients. Moreover, it improves the protection of joints and other parts of the body, significantly reduces the incidence of disability during the life cycle, and helps hemophilia A patients to keep vitality of life and return to the normal life. It is expected to fully satisfy the patients' demand, improve patients' treatment compliance, and lower the economic burden of patients' families as well as the society, demonstrating great social significance.