China NMPA Approves Pfizer’s Matazisimab (You Ruiting) for Routine Prophylaxis in Hemophilia Patients with Inhibitors | iPharmaCenter

First recombinant monoclonal antibody therapy approved in China for 12+ year-old hemophilia A or B patients with factor VIII/IX inhibitors

Beijing, China – November 21, 2025 – The National Medical Products Administration (NMPA) of China has granted marketing approval to Pfizer Inc. for its recombinant monoclonal antibody injection matazisimab (brand name You Ruiting). This therapy is indicated for routine prophylaxis to prevent bleeding episodes in patients aged 12 years and older with hemophilia A or B who have developed inhibitors against coagulation factors VIII or IX and weigh at least 35 kg.

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BASIS Trial Data Support China NMPA Approval of Matazisimab​

In the pivotal phase 3 BASIS trial in people living with severe hemophilia A and moderately severe to severe hemophilia B without inhibitors, prophylactic treatment with marstacimab achieved a statistically significant and clinically meaningful reduction in annualized bleeding rate (ABR) compared with standard factor replacement regimens.

A total of 116 participants received once‑weekly subcutaneous marstacimab for 12 months following a six‑month lead‑in period on usual‑care intravenous FVIII or FIX prophylaxis or on‑demand therapy; among those previously treated with on‑demand factor replacement, marstacimab reduced bleeds by approximately 92%, while in those previously on prophylaxis it delivered a 35% reduction in ABR.

Matazisimab represents a novel biologic treatment option targeting a high-need patient population. Patients with inhibitors face increased bleeding risk and complications, and current treatment options have limitations. Matazisimab acts by modulating the coagulation pathway to enhance hemostatic control and reduce annualized bleeding rates, improving long-term outcomes for adolescents and adults with inhibitor-positive hemophilia.