Pfizer's TFPI Antibody Marstacimab (Hympavzi) Becomes First-in-Class Global Approval for Hemophilia A and B

▎Armstrong

On October 11, 2024, Pfizer announced that the TFPI antibody Marstacimab had been approved by the FDA for marketing, used to treat Hemophilia A and B, with the trade name Hympavzi.

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 progressed the fastest, but due to thrombotic events leading to a pause in Phase III clinical trials, it was overtaken by Pfizer.

Summary

In China, Alphamab Oncology's KN057 is the first TFPI antibody, currently in phase III clinical trials, while Apyrogen's AP017 is the second TFPI antibody produced in China, currently in phase I clinical trials. The treatment of hemophilia 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 dose.