WO2026126079 - A STABLE PHARMACEUTICAL COMPOSITION OF FUSION PROTEIN
National phase entry is expected:
Publication Number
WO/2026/126079
Publication Date
18.06.2026
International Application No.
PCT/IB2025/062608
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
DUBEY, Vaibhav
GUPTA, Sudharti
Priority Data
202421097764
11.12.2024
IN
Application details
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International Searching Authority |
USPTO
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| Recordal of a Change of the Applicant's Name/Address |
Change of Applicant's Name and Address
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| Type of Assignment |
The Standard Agent's Assignment
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| Applicant's Legal Status |
Legal Entity
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| Entry into National Phase under |
Chapter I
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| Patent Delivery |
Send the Letters Patent by Courier
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| Translation |
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Quotation for National Phase entry
| Country | Stages | Total | |
|---|---|---|---|
| China | Filing, Examination, Granting | 4147 | |
| EPO | Filing, Examination, Granting | 64984 | |
| Japan | Filing, Examination, Granting | 4100 | |
| South Korea | Filing, Examination, Granting | 6105 | |
| USA | Filing, Examination, Granting | 18110 |
Total:
97,446
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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 consists of a single sugar and is essentially free of mannitol. The present invention discloses a stable lyophilized composition of a Thrombopoietin Receptor Agonist (TPO-RA) fusion protein that maintains high purity of the monomer and low level of product-related impurities, even at elevated temperatures or during long-term storage, the formulation comprises a suitable buffering agent, a stabilizer and a surfactant. The use of specific buffer and excipients helps 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 essentiellement constituée d'un seul sucre et étant sensiblement exempte de mannitol. La présente 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, y compris à des températures élevées ou pendant un stockage à long terme, la formulation comprenant un agent tampon, un stabilisant et un tensioactif appropriés. L'utilisation d'un tampon et d'excipients spécifiques contribue à 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.