Under review!

Transfer from: Pharmaceutical Guanlan

China National Medical Products Administration (NMPA) official website registration progress query, the listing application of recombinant human coagulation factor VIII (SCT800) for Shenzhou cell injection has been updated to "under approval"

Screenshot source: NMPA official website

Hemophilia A is a bleeding disorder caused by the lack of Coagulation Factor Ⅷ (FⅧ).

According to the disclosed information, SCT800 China cell is developed, both the process and albumin-free formulation of recombinant coagulation factor Ⅷ third generation product intended for the treatment of hemophilia A

According to the information on the official website of Shenzhou Cell, SCT800 has completed the Phase 3 on-demand treatment study for patients with hemophilia A ≥ 12 years old, and is conducting a Phase 3 preventive treatment study for patients with hemophilia A ≥ 12 years old.

In November 2019, Shenzhou Cell submitted a new drug listing application for SCT800 in China, which was also included in the priority review by the NMPA Center for Drug Evaluation (CDE) for rare diseases

Screenshot source: CDE official website

According to data published in pivotal clinical study of three well-known in the field of hemophilia journal Haemophilia in June 2021, SCT800 in the prevention and treatment of adolescent adult patients with severe hemophilia A, its efficacy and safety have been verified

The results showed that the estimated mean annualized bleeding rate (ABR) after SCT800 was 2.

In terms of safety, 53.

According to data from the World Federation of Hemophilia (WFH), “1 in 1,000 people have a bleeding disorder, but 75% of patients cannot receive effective treatment”