For hemophilia A, Shengsi Biologics long-acting coagulation factor declares and goes on the market

On December 23, Jiangsu Shengsi Biopharmaceutical Co.
, Ltd.
(hereinafter referred to as "Shengsi Biopharmaceutical") announced that the company’s research and development of a new class 1 drug "recombinant human coagulation factor VIII-Fc fusion protein for injection" has been approved by the Chinese government.
The Drug Administration (NMPA) accepts
.

According to the press release, this is a long-acting recombinant factor VIII product intended for bleeding control and preventive treatment of hemophilia A patients with congenital factor VIII deficiency

Screenshot source: CDE official website

Hemophilia A is a bleeding disease caused by the lack of coagulation factor Ⅷ.
It is a recessive genetic disease linked to the X chromosome and is mainly caused by mutations in the coagulation factor Ⅷ gene
.

If repeated bleeding is not treated in time, it can lead to joint deformities or pseudo-tumor formation.

Suns Biotech focuses on unmet clinical needs in the fields of global hemophilia, metabolic diseases and anti-tumor
.

Based on the company's protein expression platform and protein modification platform, Suns Biosciences is developing recombinant long-acting and ultra-long-acting coagulation factor products (coagulation factors Ⅷ, Ⅸ and Ⅶ)

The "recombinant human coagulation factor VIII-Fc fusion protein for injection" declared for marketing this time is the first class 1 new drug in the long-acting recombinant coagulation factor series pipeline of Suns Biotech
.

The clinical studies that have been carried out have shown that: the treatment under investigation can not only effectively reduce the frequency of patients' medication, reduce the time and pain of drug injection for patients with hemophilia A, but also can maintain a high level of coagulation factor Ⅷ in the body for a long time, greatly reducing The number of spontaneous bleeding significantly improves the quality and quality of life of patients; in addition, the product under development can also improve the protection of patients’ joints and other parts, greatly reduce the incidence of disability during the life cycle of patients, and make the life status of patients with hemophilia A better Be active and return to a normal life

According to the press release, the current demand for medicines for patients with hemophilia A in China has gradually shifted from initial bleeding control to bleeding prevention
.

Among children with hemophilia A, the proportion of preventive treatment has risen sharply

Reference materials:

Reference materials:

[1] The first domestic long-acting eight-factor product listing application has been accepted.

[1] The first domestic long-acting eight-factor product listing application has been accepted.