PHARMACEUTICAL COMPOSITIONS COMPRISING AN ANTI-CD38 ANTIBODY AND A HYALURONIDASE

AR135193A1Pending Publication Date: 2026-07-22JANSSEN BIOTECH INC

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Patent Information

Application Number: ARP20250100327
Authority / Receiving Office: AR · AR
Patent Type: Applications
Current Assignee / Owner
Priority Date: 2015-11-03
Filing Date: 2025-02-06
Publication Date: 2026-07-22

Application Information

Patent Timeline

03 Nov 2015

Priority

06 Feb 2025

Application

ARP20250100327

22 Jul 2026

Publication

AR135193A1

IPC: A61K31/573; A61K38/47; A61K39/395; A61K47/26; A61K9/00; C07K16/28

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Claims

The present invention relates to subcutaneous formulations of anti-CD38 antibodies and their uses.

1. A pharmaceutical composition characterized in that it comprises: a) an anti-CD38 antibody comprising a heavy chain variable region (HV) of SEQ ID No. 4 and a light chain variable region (LV) of SEQ ID No. 5; and b) recombinant hyaluronidase rHuPH20, wherein the pharmaceutical composition comprises 1,800 mg of the anti-CD38 antibody and has a hyaluronidase enzyme activity of 30,000 U.

7. A pharmaceutical composition characterized in that it comprises daratumumab, histidine, sorbitol and a surfactant, wherein the turbidity of the pharmaceutical composition is approximately 6 Nephelometric Turbidity Units (NTU) or less after storage for 1 month at 25°C and 60% relative humidity.