WO2026126081 - A STABLE PHARMACEUTICAL COMPOSITION OF FUSION PROTEIN
National phase entry is expected:
Publication Number
WO/2026/126081
Publication Date
18.06.2026
International Application No.
PCT/IB2025/062610
International Filing Date
09.12.2025
Title **
[English]
A STABLE PHARMACEUTICAL COMPOSITION OF FUSION PROTEIN
[French]
COMPOSITION PHARMACEUTIQUE STABLE DE PROTÉINE DE FUSION
Applicants **
KASHIV BIOSCIENCES, LLC
Inventors
BHATT, Chandresh
PATEL, Keyur
Priority Data
202421097800
11.12.2024
IN
Application details
| Total Number of Claims/PCT | * |
| Number of Independent Claims | * |
| Number of Priorities | * |
| Number of Multi-Dependent Claims | * |
| Number of Drawings | * |
| Pages for Publication | * |
| Number of Pages with Drawings | * |
| Pages of Specification | * |
| * | |
| Number of Office Actions | * |
| * | |
International Searching Authority |
USPTO
* |
| * | |
| Recordal of a Change of the Applicant's Name/Address |
Change of Applicant's Name and Address
* |
| Type of Assignment |
The Standard Agent's Assignment
* |
| Applicant's Legal Status |
Legal Entity
* |
| * | |
| * | |
| * | |
| * | |
| * | |
| Entry into National Phase under |
Chapter I
* |
| Patent Delivery |
Send the Letters Patent by Courier
* |
| Translation |
|
* The data is based on automatic recognition. Please verify and amend if necessary.
** IP-Coster compiles data from publicly available sources. If this data includes your personal information, you can contact us to request its removal.
Quotation for National Phase entry
| Country | Stages | Total | |
|---|---|---|---|
| China | Filing, Examination, Granting | 3233 | |
| EPO | Filing, Examination, Granting | 29610 | |
| Japan | Filing, Examination, Granting | 3243 | |
| South Korea | Filing, Examination, Granting | 4312 | |
| USA | Filing, Examination, Granting | 13110 |
Total:
53,508
Contact Us
Abstract[English]
The present invention relates to a stable pharmaceutical composition of a pharmacologically active fusion protein,, comprising a suitable buffering agent, stabilizer and surfactant wherein the composition essentially consisting of single sugar and essentially free of mannitol wherein the formulation maintains the purity of the fusion protein at least more than 77%. The invention discloses stable lyophilized composition of Thrombopoietin Receptor Agonist (TPO-RA) fusion protein that maintains high purity of the monomer and low level of product-related impurities, at elevated temperatures or during long-term storage, the formulation comprising a suitable buffering agent, stabilizer and surfactant wherein the composition essentially consisting of single sugar and essentially free of mannitol. The use of specific buffer systems (arginine acetate) and excipients help to ensure the stability of the peptibody during the freeze- drying (lyophilization) process and subsequent storage, thereby improving the product's shelf life and stability.[French]
La présente invention concerne une composition pharmaceutique stable d'une protéine de fusion pharmacologiquement active, comprenant un agent tampon, un stabilisant et un tensioactif appropriés, la composition étant constituée essentiellement d'un seul sucre et sensiblement exempte de mannitol, la formulation conservant la pureté de la protéine de fusion au moins supérieure à 77 %. L'invention divulgue une composition lyophilisée stable de protéine de fusion agoniste du récepteur de la thrombopoïétine (TPO-RA) qui permet de maintenir une pureté élevée du monomère et un faible taux d'impuretés liées au produit, à des températures élevées ou pendant un stockage à long terme, la formulation comprenant un agent tampon, un stabilisant et un tensioactif appropriés, la composition étant constituée essentiellement d'un seul sucre et sensiblement exempte de mannitol. L'utilisation de systèmes tampons (acétate d'arginine) et d'excipients spécifiques permet d'assurer la stabilité du pepticorps pendant le processus de lyophilisation et le stockage ultérieur, ce qui permet d'améliorer la durée de conservation et la stabilité du produit.