Pfizer Submits NMPA Application for Marstacimab, the First-in-Class Anti-TFPI Antibody for Hemophilia A and B

▎Armstrong

On August 13, 2024, Pfizer's TFPI antibody Marstacimab had its marketing application accepted by the NMPA. In December last year, Marstacimab had already been submitted for marketing approval in Europe and the United States.

In the competition for the development of TFPI antibodies, Novo Nordisk's Concizumab, Bayer's BAY-1093884, and Pfizer's Marstacimab are in the same tier. Among them, Novo Nordisk's Concizumab once made the fastest progress, but its Phase III clinical trial was suspended due to thrombotic events, allowing Pfizer to surpass it.

Summary

In China, Alphamab Oncology's KN057 is the first TFPI antibody, currently in phase II clinical trials, while Antengene’s AP017 is the second TFPI antibody produced in China, currently in phase I clinical trials. Hemophilia treatment mainly involves replacement therapy with clotting factors and FIX/FX bispecific antibodies. The success of TFPI antibodies provides a new treatment option for hemophilia patients. Additionally, AAV gene therapies for hemophilia are expected to offer more convenient treatment methods, with long-term efficacy achieved after a single administration.