| Sonstiges: |
- Nachgewiesen in: USPTO Patent Applications
- Sprachen: English
- Document Number: 20230346959
- Publication Date: November 2, 2023
- Appl. No: 18/312292
- Application Filed: May 04, 2023
- Assignees: HANGZHOU GRAND BIOLOGIC PHARMACEUTICAL INC. (Hangzhou, CN)
- Claim: 1. A urate oxidase preparation, comprising: an active ingredient selected from a polyethylene glycol-modified urate oxidase; and an excipient selected from a buffer reagent, wherein the buffer reagent comprises at least one of phosphate or hydrochloride.
- Claim: 2. The urate oxidase preparation according to claim 1, wherein at least 11 of the following amino acid sites in the urate oxidase have a PEG modification: T1, K3, K4, K30, K35, K76, K79, K97, K112, K116K120, K152, K179, K222, K231, K266, K272, K285, K291, and K293, and the amino acid sites are positioned based on an amino acid sequence set forth as SEQ ID NO: 1.
- Claim: 3. The urate oxidase preparation according to claim 2, wherein at least one, at least two, at least three, or four of the following four amino acid sites in the urate oxidase have a PEG modification: K3, K35, K222 and K231.
- Claim: 4. The urate oxidase preparation according to claim 1, wherein the polyethylene glycol has a monomethoxy group or a hydroxyl group.
- Claim: 5. The urate oxidase preparation according to claim 1, wherein the polyethylene glycol is of a linear or branched structure.
- Claim: 6. The urate oxidase preparation according to claim 1, wherein the polyethylene glycol is coupled to the urate oxidase via an amide bond.
- Claim: 7. The urate oxidase preparation according to claim 1, wherein the polyethylene glycol is a modified polyethylene glycol, and a modification group of the modified polyethylene glycol is at least one selected from the group consisting of N-hydroxysuccinimide, N-hydroxysuccinimidyl carbonate, N-hydroxysuccinimidyl acetate, N-hydroxysuccinimidyl propionate, N-hydroxysuccinimidyl butyrate, N-hydroxysuccinimidyl succinate, and bis(p-nitrophenyl) carbonate, preferably N-hydroxysuccinimidyl propionate.
- Claim: 8. The urate oxidase preparation according to claim 1, wherein the urate oxidase has an amino acid sequence set forth as any one of SEQ ID NOs: 1 to 7; or the urate oxidase is a polypeptide having at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, or at least 99% identity with any of SEQ ID NOs: 1 to 7; or the urate oxidase is a polypeptide having an amino acid sequence set forth as any one of SEQ ID NOs: 1 to 7 in which one or more amino acids are substituted, deleted and/or added.
- Claim: 9. The urate oxidase preparation according to claim 1, wherein the urate oxidase has an amino acid sequence set forth as any one of SEQ ID NOs: 1 to 4.
- Claim: 10. The urate oxidase preparation according to claim 1, wherein the buffer reagent comprises at least one selected from the group consisting of disodium hydrogen phosphate, sodium dihydrogen phosphate, and sodium chloride.
- Claim: 11. The urate oxidase preparation according to claim 1, wherein the urate oxidase preparation has a pH of 7 to 9, preferably a pH of 7.4 to 8.2.
- Claim: 12. The urate oxidase preparation according to claim 8, wherein a mass ratio of the polyethylene glycol-modified urate oxidase to the buffer reagent is (5 to 6): (6 to 37), preferably 6:10.
- Claim: 13. The urate oxidase preparation according to claim 8, wherein the buffer reagent comprises phosphate, and a mass ratio of the polyethylene glycol-modified urate oxidase to the phosphate is (5 to 6): (1 to 7), wherein the phosphate is disodium hydrogen phosphate and sodium dihydrogen phosphate.
- Claim: 14. The urate oxidase preparation according to claim 8, wherein the buffer reagent comprises sodium chloride, and a mass ratio of the polyethylene glycol-modified urate oxidase to the sodium chloride is (5 to 6): (5 to 30).
- Claim: 15. The urate oxidase preparation according to claim 8, wherein the buffer reagent comprises phosphate and sodium chloride, and a mass ratio of the phosphate to the sodium chloride is (1 to 7): (5 to 30), wherein the phosphate is disodium hydrogen phosphate and/or sodium dihydrogen phosphate.
- Claim: 16. The urate oxidase preparation according to claim 1, wherein a dosage form of the urate oxidase preparation comprises at least one of liquid, semi-solid, or solid.
- Claim: 17. The urate oxidase preparation according to claim 1, wherein the preparation is in a single-dose form, each dose of the preparation containing 6 mg of the polyethylene glycol-modified urate oxidase.
- Claim: 18. A pharmaceutical composition, comprising the urate oxidase preparation according to claim 1.
- Claim: 19. The pharmaceutical composition according to claim 18, further comprising an additional drug for the treatment or prevention of hyperuricemia and hyperuricemia-related diseases.
- Claim: 20. A method for treating or preventing hyperuricemia and hyperuricemia-related diseases, comprising: administering to a subject a pharmaceutically acceptable amount of the urate oxidase preparation comprising: an active ingredient selected from a polyethylene glycol-modified urate oxidase; and an excipient selected from a buffer reagent, wherein the buffer reagent comprises at least one of phosphate or hydrochloride.
- Current International Class: 61; 12; 61
|
