Biotest obtains approval for new human fibrinogen Prufibry in Germany

EQS-News: Biotest AG / Key word(s): Regulatory Approval Biotest obtains approval for new human fibrinogen Prufibry in Germany 13.11.2025 / 10:07 CET/CEST The issuer is solely responsible for the content of this announcement.

PRESS RELEASE

Biotest obtains approval for new human fibrinogen Prufibry in Germany

• New life-saving therapy for patients with congenital and acquired fibrinogen deficiency
• Clinical studies demonstrate efficacy and safety in bleeding control and surgical settings
• Important expansion to Biotest’s intensive care and coagulation factor portfolio
• Produced at the highly efficient Biotest Next Level facility in Dreieich

Dreieich, 13 November 2025.  Biotest AG, part of the Grifols Group, announced today that the German competent authority, the Paul-Ehrlich-Institut, has approved Prufibry (human fibrinogen; development name BT524) for the German market. Biotest’s human fibrinogen is a highly purified product with a precisely defined amount of fibrinogen, allowing for a predictable response and a rapid replenishment of fibrinogen, which is important in these critical moments.

“Prufibry expands Biotest’s product portfolio in the field of intensive care and coagulation disorders with a new, highly purified plasma protein,” emphasises Dr Jörg Schüttrumpf, Chief Executive Officer of Biotest AG. “With this approval, patients suffering from congenital and acquired fibrinogen deficiency will gain access to an effective, reliable and safe therapy to prevent and control life-threatening bleeding events especially in surgical and trauma settings.”

Clinical development and indications

This approval is based on a comprehensive clinical development program including pivotal Phase III trials. The studies demonstrated that BT524 effectively restored fibrinogen levels and controlled bleeding episodes in patients with congenital afibrinogenemia and hypofibrinogenemia. In addition, perioperative use of BT524 in major surgeries confirmed its efficacy in preventing excessive bleeding when standard coagulation support was insufficient.