Zusammensetzung mit Sotatercept und Varianten davon sowie Zugehörige Verfahren und Verwendungen

Details

Veröffentlichungs-Nr.

EP4782463

Anmeldetag

1. April 2026

Veröffentlichung

29. Juli 2026

Rechtsraum

EP

Abstract

The present application provides a composition comprising Sotatercept and a variant thereof, as well as related methods and uses, wherein the variant has a peptide bond cleavage occurred between arginine at position 4 and serine at position 5 (Arg(4)-Ser(5)) in the amino acid sequence (SEQ ID NO:2) of one or two monomeric peptide chains of sotatercept, and as calculated by a peptide mass fingerprinting analysis, the content of the variant is less than or equal to about 10%. The present application also provides a pharmaceutical formulation comprising the above composition and a method of making the same. The present application further provides a method for detecting the above variant and use of the variant in the quality inspection or quality control of a sotatercept-containing product.

Anmelder

Firma

QILU PHARMACEUTICAL CO., LTD.

Land

🇨🇳 China